Trial Outcomes & Findings for PROspective Multicenter Imaging Study for Evaluation of Chest Pain (NCT NCT01174550)
NCT ID: NCT01174550
Last Updated: 2016-02-29
Results Overview
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10003 participants
Primary outcome timeframe
90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Results posted on
2016-02-29
Participant Flow
Participant milestones
| Measure |
Functional Diagnostic Tests
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
Anatomic Diagnostic Test
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Overall Study
STARTED
|
5007
|
4996
|
|
Overall Study
COMPLETED
|
3737
|
4123
|
|
Overall Study
NOT COMPLETED
|
1270
|
873
|
Reasons for withdrawal
| Measure |
Functional Diagnostic Tests
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
Anatomic Diagnostic Test
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Overall Study
Death
|
75
|
74
|
|
Overall Study
Lost to Follow-up
|
652
|
510
|
|
Overall Study
Withdrawal by Subject
|
543
|
289
|
Baseline Characteristics
PROspective Multicenter Imaging Study for Evaluation of Chest Pain
Baseline characteristics by cohort
| Measure |
Functional Diagnostic Tests
n=5007 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
Anatomic Diagnostic Test
n=4996 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Total
n=10003 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2675 Participants
n=5 Participants
|
2595 Participants
n=7 Participants
|
5270 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2332 Participants
n=5 Participants
|
2401 Participants
n=7 Participants
|
4733 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 monthsTime to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=4996 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=5007 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Time to Primary Endpoint
90 days
|
1.0 Percentage of participants with an event
|
1.1 Percentage of participants with an event
|
|
Time to Primary Endpoint
6 months
|
1.2 Percentage of participants with an event
|
1.4 Percentage of participants with an event
|
|
Time to Primary Endpoint
12 months
|
1.8 Percentage of participants with an event
|
1.9 Percentage of participants with an event
|
|
Time to Primary Endpoint
18 months
|
2.5 Percentage of participants with an event
|
2.6 Percentage of participants with an event
|
|
Time to Primary Endpoint
24 months
|
2.9 Percentage of participants with an event
|
2.8 Percentage of participants with an event
|
|
Time to Primary Endpoint
30 months
|
3.5 Percentage of participants with an event
|
3.5 Percentage of participants with an event
|
|
Time to Primary Endpoint
36 months
|
4.6 Percentage of participants with an event
|
3.8 Percentage of participants with an event
|
|
Time to Primary Endpoint
42 months
|
5.3 Percentage of participants with an event
|
5.1 Percentage of participants with an event
|
SECONDARY outcome
Timeframe: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 monthsTime to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=4996 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=5007 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
90 day
|
0.9 Percentage of participants with an event
|
1.0 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
6 month
|
1.2 Percentage of participants with an event
|
1.4 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
12 month
|
1.8 Percentage of participants with an event
|
1.9 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
18 month
|
2.5 Percentage of participants with an event
|
2.5 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
24 month
|
2.9 Percentage of participants with an event
|
2.8 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
30 month
|
3.5 Percentage of participants with an event
|
3.4 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
36 month
|
4.6 Percentage of participants with an event
|
3.7 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
42 month
|
5.2 Percentage of participants with an event
|
5.1 Percentage of participants with an event
|
SECONDARY outcome
Timeframe: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 monthsTime to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=4996 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=5007 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Time to Death or Myocardial Infarction (MI)
90 Days
|
0.3 Percentage of participants with an event
|
0.6 Percentage of participants with an event
|
|
Time to Death or Myocardial Infarction (MI)
6 months
|
0.4 Percentage of participants with an event
|
0.9 Percentage of participants with an event
|
|
Time to Death or Myocardial Infarction (MI)
12 months
|
0.8 Percentage of participants with an event
|
1.2 Percentage of participants with an event
|
|
Time to Death or Myocardial Infarction (MI)
18 months
|
1.3 Percentage of participants with an event
|
1.8 Percentage of participants with an event
|
|
Time to Death or Myocardial Infarction (MI)
24 months
|
1.7 Percentage of participants with an event
|
2.0 Percentage of participants with an event
|
|
Time to Death or Myocardial Infarction (MI)
30 months
|
2.2 Percentage of participants with an event
|
2.7 Percentage of participants with an event
|
|
Time to Death or Myocardial Infarction (MI)
36 months
|
3.3 Percentage of participants with an event
|
3.0 Percentage of participants with an event
|
|
Time to Death or Myocardial Infarction (MI)
42 months
|
3.9 Percentage of participants with an event
|
4.2 Percentage of participants with an event
|
SECONDARY outcome
Timeframe: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 monthsTime to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=4996 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=5007 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Time to Major Complications From Cardiovascular (CV) Procedures
90 day
|
0.1 Percentage of participants with an event
|
0.3 Percentage of participants with an event
|
|
Time to Major Complications From Cardiovascular (CV) Procedures
6 month
|
0.2 Percentage of participants with an event
|
0.5 Percentage of participants with an event
|
|
Time to Major Complications From Cardiovascular (CV) Procedures
12 month
|
0.5 Percentage of participants with an event
|
0.8 Percentage of participants with an event
|
|
Time to Major Complications From Cardiovascular (CV) Procedures
18 month
|
1.0 Percentage of participants with an event
|
1.1 Percentage of participants with an event
|
|
Time to Major Complications From Cardiovascular (CV) Procedures
24 month
|
1.2 Percentage of participants with an event
|
1.4 Percentage of participants with an event
|
|
Time to Major Complications From Cardiovascular (CV) Procedures
30 month
|
1.7 Percentage of participants with an event
|
1.9 Percentage of participants with an event
|
|
Time to Major Complications From Cardiovascular (CV) Procedures
36 month
|
2.6 Percentage of participants with an event
|
2.2 Percentage of participants with an event
|
|
Time to Major Complications From Cardiovascular (CV) Procedures
42 month
|
3.1 Percentage of participants with an event
|
3.2 Percentage of participants with an event
|
SECONDARY outcome
Timeframe: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 monthsTime to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=4996 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=5007 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
90 days
|
4.4 Percentage of participants with an event
|
5.2 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
6 months
|
4.6 Percentage of participants with an event
|
5.6 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
12 months
|
5.2 Percentage of participants with an event
|
6.1 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
18 months
|
5.9 Percentage of participants with an event
|
6.7 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
24 months
|
6.3 Percentage of participants with an event
|
6.9 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
30 months
|
6.9 Percentage of participants with an event
|
7.6 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
36 months
|
8.0 Percentage of participants with an event
|
7.9 Percentage of participants with an event
|
|
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
42 months
|
8.7 Percentage of participants with an event
|
9.1 Percentage of participants with an event
|
SECONDARY outcome
Timeframe: Up to 90 days following participant randomizationPercentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=4996 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=5007 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization
|
3.4 Percentage of events
Standard Error 0.3
|
4.3 Percentage of events
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 90 days and 3 years cumulativePopulation: Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.
Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=4818 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=4831 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Medical Cost
90 days
|
2494 Per participant cost in US dollars
Interval 2233.0 to 2821.0
|
2240 Per participant cost in US dollars
Interval 1599.0 to 3119.0
|
|
Medical Cost
3 years cumulative
|
7213 Per participant cost in US dollars
Interval 6501.0 to 8156.0
|
6586 Per participant cost in US dollars
Interval 5683.0 to 7772.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months 24 monthsPopulation: The number of participants were limited due to budget constraints.
Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=2982 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=3003 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Quality of Life (QOL) as Measured by Duke Activity Status Index
6 months
|
30.5 participant score
Interval 10.7 to 44.7
|
30.2 participant score
Interval 15.2 to 44.7
|
|
Quality of Life (QOL) as Measured by Duke Activity Status Index
12 months
|
29.2 participant score
Interval 13.5 to 44.7
|
31.2 participant score
Interval 15.2 to 44.7
|
|
Quality of Life (QOL) as Measured by Duke Activity Status Index
24 months
|
31.5 participant score
Interval 16.0 to 45.5
|
31.2 participant score
Interval 16.0 to 45.5
|
|
Quality of Life (QOL) as Measured by Duke Activity Status Index
Baseline
|
21.5 participant score
Interval 10.7 to 38.2
|
22.9 participant score
Interval 10.0 to 39.5
|
SECONDARY outcome
Timeframe: Baseline, 6 month, 12 month, 24 monthPopulation: The number of participants were limited due to budget constraints.
Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning \& summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable \& less frequent, condition has less impact on activities, increased satisfaction with treatment, \& perception of disease has less impact on interpersonal relationships.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=2982 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=3003 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
Baseline
|
70 participant score
Interval 70.0 to 90.0
|
80 participant score
Interval 70.0 to 90.0
|
|
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
6 month
|
100 participant score
Interval 90.0 to 100.0
|
100 participant score
Interval 90.0 to 100.0
|
|
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
24 month
|
100 participant score
Interval 100.0 to 100.0
|
100 participant score
Interval 100.0 to 100.0
|
|
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
12 month
|
100 participant score
Interval 90.0 to 100.0
|
100 participant score
Interval 90.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 24 monthsPopulation: The number of participants were limited due to budget constraints.
Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning \& summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable \& less frequent, condition has less impact on activities, increased satisfaction with treatment, \& perception of disease has less impact on interpersonal relationships.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=2982 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=3003 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
Baseline
|
58.3 participant score
Interval 41.7 to 75.0
|
58.3 participant score
Interval 41.7 to 75.0
|
|
Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
6 month
|
83.3 participant score
Interval 75.0 to 91.7
|
83.3 participant score
Interval 75.0 to 100.0
|
|
Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
12 month
|
83.3 participant score
Interval 75.0 to 100.0
|
91.7 participant score
Interval 75.0 to 100.0
|
|
Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
24 month
|
91.7 participant score
Interval 75.0 to 100.0
|
91.7 participant score
Interval 75.0 to 100.0
|
SECONDARY outcome
Timeframe: 6 month, 12 month 24 monthPopulation: The number of participants were limited due to budget constraints.
Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=2982 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=3003 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing
6 months
|
43.3 % of participants
|
46.5 % of participants
|
|
Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing
12 months
|
47.3 % of participants
|
48.8 % of participants
|
|
Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing
24 months
|
52.1 % of participants
|
54.3 % of participants
|
SECONDARY outcome
Timeframe: 90 daysCumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.
Outcome measures
| Measure |
Anatomic Diagnostic Test
n=4996 Participants
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
Functional Diagnostic Tests
n=5007 Participants
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Cumulative Radiation Exposure Within 90 Days
|
10.0 milliSievert (mSv)
Interval 5.6 to 17.2
|
11.3 milliSievert (mSv)
Interval 0.0 to 13.5
|
Adverse Events
Functional Diagnostic Tests
Serious events: 161 serious events
Other events: 16 other events
Deaths: 0 deaths
Anatomic Diagnostic Test
Serious events: 168 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Functional Diagnostic Tests
n=5007 participants at risk
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
Anatomic Diagnostic Test
n=4996 participants at risk
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Cardiac disorders
Death- Cardiovascular
|
0.42%
21/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.28%
14/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Cardiac disorders
Major Bleeding
|
0.06%
3/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.06%
3/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Cardiac disorders
Myocardial Infarction
|
0.80%
40/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.60%
30/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Cardiac disorders
Stroke
|
0.04%
2/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.02%
1/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Cardiac disorders
Unstable Angina Hospitalization
|
0.82%
41/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
1.2%
61/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
General disorders
Death - Non cardiovascular known cause
|
0.54%
27/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.66%
33/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
General disorders
Death - unknown cause
|
0.54%
27/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.54%
27/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
Other adverse events
| Measure |
Functional Diagnostic Tests
n=5007 participants at risk
Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing
|
Anatomic Diagnostic Test
n=4996 participants at risk
Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing
|
|---|---|---|
|
Cardiac disorders
Any Event Potentially Related to Vasodilators
|
0.10%
5/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.00%
0/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Skin and subcutaneous tissue disorders
Mild Contrast Reaction (rash or hives)
|
0.00%
0/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.44%
22/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Skin and subcutaneous tissue disorders
Extravasion of Contrast Into Surrounding Tissue
|
0.00%
0/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.24%
12/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Cardiac disorders
Exercise Induced Hypotension
|
0.12%
6/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.00%
0/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Cardiac disorders
Stress Induced Symptoms Related to Functional Testing
|
0.08%
4/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.00%
0/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.08%
4/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.00%
0/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
Cardiac disorders
Hemodynamic Instability
|
0.04%
2/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.06%
3/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
|
General disorders
Hospital Admission Not In The Primary Endpoint
|
0.10%
5/5007 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
0.00%
0/4996 • Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place