Trial Outcomes & Findings for Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations (NCT NCT01262625)
NCT ID: NCT01262625
Last Updated: 2023-12-26
Results Overview
To compare outcomes of participants with symptoms of stable angina or angina equivalent evaluated with an anatomic imaging strategy using CCTA as initial method of computer-aided diagnosis (CAD) (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to Optimal Medical Therapy (OMT) alone. The analysis was conducted from an intent-to-treat perspective
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1050 participants
Primary outcome timeframe
up to 24 Months (depends on time of trial enrollment and funding duration)
Results posted on
2023-12-26
Participant Flow
The study opened to enrollment in May 2011 and was closed to enrollment in June 2013 due to resource limitations. The study was designed to enroll and randomize 4300 participants to the 2 study arms, but given the difficulties of recruiting enough patients to fulfill the stringent entry criteria, as well as time constraints for funding (American Recovery and Reinvestment Act award, 3-year cap), only one quarter of the planned sample size could be recruited .
Participant milestones
| Measure |
Group A: CCTA Diagnostic
Participants randomized to diagnostic evaluation using coronary computed tomographic angiography (CCTA) to determine therapeutic course of action.
CCTA: Complete diagnostic CCTA per protocol specifications.
|
Group B: SPECT MPI/ICA Diagnostic
Standard-of-care diagnostic assessment using single photon emission computed tomography myocardial perfusion imaging (SPECT MPI), possibly followed by diagnostic invasive coronary angiography (ICA) dependent on SPECT MPI results.
SPECT MPI/ICA: Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
518
|
532
|
|
Overall Study
Scan Available
|
475
|
465
|
|
Overall Study
Uninterpretable Scan
|
6
|
4
|
|
Overall Study
COMPLETED
|
516
|
531
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group A: CCTA Diagnostic
Participants randomized to diagnostic evaluation using coronary computed tomographic angiography (CCTA) to determine therapeutic course of action.
CCTA: Complete diagnostic CCTA per protocol specifications.
|
Group B: SPECT MPI/ICA Diagnostic
Standard-of-care diagnostic assessment using single photon emission computed tomography myocardial perfusion imaging (SPECT MPI), possibly followed by diagnostic invasive coronary angiography (ICA) dependent on SPECT MPI results.
SPECT MPI/ICA: Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
|
|---|---|---|
|
Overall Study
Administrative Error
|
1
|
1
|
|
Overall Study
Site Closed
|
1
|
0
|
Baseline Characteristics
Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations
Baseline characteristics by cohort
| Measure |
Group A: CCTA Diagnostic
n=516 Participants
Participants randomized to diagnostic evaluation using CCTA to determine therapeutic course of action.
CCTA: Complete diagnostic CCTA per protocol specifications.
|
Group B: SPECT MPI/ICA Diagnostic
n=531 Participants
Standard-of-care diagnostic assessment using SPECT MPI, possibly followed by diagnostic ICA dependent on SPECT MPI results.
SPECT MPI/ICA: Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
|
Total
n=1047 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 9 • n=93 Participants
|
58 years
STANDARD_DEVIATION 9 • n=4 Participants
|
58 years
STANDARD_DEVIATION 9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=93 Participants
|
244 Participants
n=4 Participants
|
477 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
283 Participants
n=93 Participants
|
287 Participants
n=4 Participants
|
570 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
467 Participants
n=93 Participants
|
468 Participants
n=4 Participants
|
935 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
73 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
150 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
400 Participants
n=93 Participants
|
415 Participants
n=4 Participants
|
815 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 24 Months (depends on time of trial enrollment and funding duration)To compare outcomes of participants with symptoms of stable angina or angina equivalent evaluated with an anatomic imaging strategy using CCTA as initial method of computer-aided diagnosis (CAD) (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to Optimal Medical Therapy (OMT) alone. The analysis was conducted from an intent-to-treat perspective
Outcome measures
| Measure |
Group A: CCTA Diagnostic
n=516 Participants
Participants randomized to diagnostic evaluation using CCTA to determine therapeutic course of action.
CCTA: Complete diagnostic CCTA per protocol specifications.
|
Group B: SPECT MPI/ICA Diagnostic
n=531 Participants
Standard-of-care diagnostic assessment using SPECT MPI, possibly followed by diagnostic ICA dependent on SPECT MPI results.
SPECT MPI/ICA: Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
|
Group A: CCTA + AHA 16 + Clinical Data Predictor
A new predictive model based upon the raw CCTA stenosis data using the AHA 16-segments: graded as normal (0%), very mild (1-29%), mild (30-49%), moderate (50-69%), or severe (≥70%) stenosis for Group A CCTA Participants. Because of the relatively few MACE events, these were grouped to \<30%, 30-49%, and ≥50% for subsequent analysis.
Hypertension was included in the model as the only clinical risk factor selected by multivariate modeling.
|
Group B: SPECT % Reversible Defect Size
Standard-of-care (SOC) diagnostic assessment using SPECT MPI (Group B)
% Reversible defect size calculated as per institutional SOC.
|
|---|---|---|---|---|
|
Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization)
No Event
|
487 Participants
|
504 Participants
|
—
|
—
|
|
Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization)
Event Occurred
|
29 Participants
|
27 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: For the secondary analyses, patients with \<1-year follow-up (defined as \<335 days) were excluded from analysis, as were ineligible patients and patients without the respective randomized scan or with an uninterpretable scan The analysis will compare the the proposed SPECT % reversible defect size vs the a modified Duke Score and the standard CCTA +AHA 16 to predict MACE events.
AUC is a unitless measure of performance ranging form 0.5 (guessing) to 1.0 (perfect predictor) that can be thought of a the proportion of correct classifications in a 2-alternative-forced-choice experiment - and for binary outcomes, it is equivalent to the C-statistic. It will be used to evaluate and compare the ability of available prognostic indices and SPECT-MPI % reversible defect size to predict revascularization or MACE using CCTA information: A CCTA Modified Duke index A CCTA index including the 16 individual American Heart Association (AHA) segments A CCTA including the 16 individual AHA segments and clinical data and compare them to the SPECT % reversible defect size results
Outcome measures
| Measure |
Group A: CCTA Diagnostic
n=401 Participants
Participants randomized to diagnostic evaluation using CCTA to determine therapeutic course of action.
CCTA: Complete diagnostic CCTA per protocol specifications.
|
Group B: SPECT MPI/ICA Diagnostic
n=401 Participants
Standard-of-care diagnostic assessment using SPECT MPI, possibly followed by diagnostic ICA dependent on SPECT MPI results.
SPECT MPI/ICA: Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
|
Group A: CCTA + AHA 16 + Clinical Data Predictor
n=401 Participants
A new predictive model based upon the raw CCTA stenosis data using the AHA 16-segments: graded as normal (0%), very mild (1-29%), mild (30-49%), moderate (50-69%), or severe (≥70%) stenosis for Group A CCTA Participants. Because of the relatively few MACE events, these were grouped to \<30%, 30-49%, and ≥50% for subsequent analysis.
Hypertension was included in the model as the only clinical risk factor selected by multivariate modeling.
|
Group B: SPECT % Reversible Defect Size
n=378 Participants
Standard-of-care (SOC) diagnostic assessment using SPECT MPI (Group B)
% Reversible defect size calculated as per institutional SOC.
|
|---|---|---|---|---|
|
Prediction of Response (MACE/Revascularization) at 1 Year Using: Modified Duke Score or CCTA + AHA 16 Predictor/CCTA+AHA 16+Clinical Data Predictor or SPECT% Reversible Defect Size Reported as Receiver Operating Characteristic (ROC) Area Under Curve (AUC)
|
0.87 unitless
Interval 0.81 to 0.94
|
0.92 unitless
Interval 0.87 to 0.96
|
0.93 unitless
Interval 0.89 to 0.97
|
0.73 unitless
Interval 0.59 to 0.88
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: Only cases with and an available screen result and both baseline and 1-year surveys completed are included in this analysis
SF36+SAQ at baseline and to a subset of participants, stratified by diagnostic examination, at 12 months after enrollment to monitor angina symptoms and their impact on Quality of life. The Short Form-36 (SF36) is a 36 item overall health status/Quality of Life collected in 8 domains. Scales are standardized with scores ranging from 0-100. Higher scores= better health status. The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item, cardiac disease-related quality-of-life measure collected in 5 domains. scales are standardized with scores ranging from 0-100. Higher scores= better health status. Positive cardiac findings on diagnostic testing are defined as: 1. 50% stenosis on CCTA or un-evaluable left main, or proximal and mid segments of all other epicardial arteries (right coronary artery, left anterior descending artery, or left circumflex artery); and 2. 10% reversible defect on SPECT MPI or evidence of Transient Ischemic Dilation (TID) accompanied by ECG
Outcome measures
| Measure |
Group A: CCTA Diagnostic
n=132 Participants
Participants randomized to diagnostic evaluation using CCTA to determine therapeutic course of action.
CCTA: Complete diagnostic CCTA per protocol specifications.
|
Group B: SPECT MPI/ICA Diagnostic
n=155 Participants
Standard-of-care diagnostic assessment using SPECT MPI, possibly followed by diagnostic ICA dependent on SPECT MPI results.
SPECT MPI/ICA: Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
|
Group A: CCTA + AHA 16 + Clinical Data Predictor
n=42 Participants
A new predictive model based upon the raw CCTA stenosis data using the AHA 16-segments: graded as normal (0%), very mild (1-29%), mild (30-49%), moderate (50-69%), or severe (≥70%) stenosis for Group A CCTA Participants. Because of the relatively few MACE events, these were grouped to \<30%, 30-49%, and ≥50% for subsequent analysis.
Hypertension was included in the model as the only clinical risk factor selected by multivariate modeling.
|
Group B: SPECT % Reversible Defect Size
n=10 Participants
Standard-of-care (SOC) diagnostic assessment using SPECT MPI (Group B)
% Reversible defect size calculated as per institutional SOC.
|
|---|---|---|---|---|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Role emotional: Baseline
|
47.9 score on a scale
Standard Deviation 12.07
|
48.08 score on a scale
Standard Deviation 11.12
|
44.96 score on a scale
Standard Deviation 10.16
|
48.51 score on a scale
Standard Deviation 9.77
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Mental health: Baseline
|
49.98 score on a scale
Standard Deviation 10.16
|
48.51 score on a scale
Standard Deviation 9.77
|
47.83 score on a scale
Standard Deviation 9.36
|
50.01 score on a scale
Standard Deviation 7.39
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Physical limitation: Baseline
|
67.50 score on a scale
Standard Deviation 15.83
|
67.12 score on a scale
Standard Deviation 17.20
|
65.20 score on a scale
Standard Deviation 16.67
|
67.41 score on a scale
Standard Deviation 17.36
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Angina stability: Baseline
|
44.34 score on a scale
Standard Deviation 31.42
|
48.87 score on a scale
Standard Deviation 32.71
|
40.98 score on a scale
Standard Deviation 30.32
|
38.00 score on a scale
Standard Deviation 27.41
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Angina frequency: Baseline
|
77.38 score on a scale
Standard Deviation 15.24
|
79.79 score on a scale
Standard Deviation 15.40
|
74.25 score on a scale
Standard Deviation 16.15
|
75.00 score on a scale
Standard Deviation 15.81
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Treatment satisfaction: Baseline
|
84.64 score on a scale
Standard Deviation 15.57
|
85.87 score on a scale
Standard Deviation 15.95
|
85.85 score on a scale
Standard Deviation 15.41
|
82.94 score on a scale
Standard Deviation 11.91
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Disease perception: Baseline
|
58.74 score on a scale
Standard Deviation 20.18
|
59.33 score on a scale
Standard Deviation 19.81
|
54.38 score on a scale
Standard Deviation 19.06
|
62.50 score on a scale
Standard Deviation 19.74
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Physical component: 1-Year
|
47.44 score on a scale
Standard Deviation 10.66
|
46.39 score on a scale
Standard Deviation 10.4
|
47.27 score on a scale
Standard Deviation 8.66
|
52.51 score on a scale
Standard Deviation 5.04
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Physical functioning: 1-Year
|
46.96 score on a scale
Standard Deviation 10.77
|
47.35 score on a scale
Standard Deviation 10.46
|
46.56 score on a scale
Standard Deviation 9.31
|
51.77 score on a scale
Standard Deviation 5.97
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Role-physical: 1-Year
|
48.14 score on a scale
Standard Deviation 11.28
|
46.00 score on a scale
Standard Deviation 11.07
|
48.38 score on a scale
Standard Deviation 9.20
|
53.42 score on a scale
Standard Deviation 4.65
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Bodily pain: 1-Year
|
47.96 score on a scale
Standard Deviation 10.15
|
46.62 score on a scale
Standard Deviation 10.16
|
45.91 score on a scale
Standard Deviation 10.13
|
53.03 score on a scale
Standard Deviation 7.14
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: General health: 1-Year
|
49.10 score on a scale
Standard Deviation 10.74
|
46.40 score on a scale
Standard Deviation 10.86
|
46.84 score on a scale
Standard Deviation 9.84
|
53.55 score on a scale
Standard Deviation 7.64
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Mental comp: 1-Year
|
50.11 score on a scale
Standard Deviation 10.82
|
48.11 score on a scale
Standard Deviation 10.96
|
46.69 score on a scale
Standard Deviation 11.50
|
53.51 score on a scale
Standard Deviation 6.93
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Vitality: 1-Year
|
50.09 score on a scale
Standard Deviation 40.51
|
47.78 score on a scale
Standard Deviation 11.49
|
48.72 score on a scale
Standard Deviation 11.15
|
53.96 score on a scale
Standard Deviation 6.45
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Social functioning: 1-Year
|
48.72 score on a scale
Standard Deviation 11.15
|
53.96 score on a scale
Standard Deviation 6.45
|
48.54 score on a scale
Standard Deviation 10.77
|
46.72 score on a scale
Standard Deviation 11.21
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Role emotional: 1-Year
|
48.43 score on a scale
Standard Deviation 11.07
|
46.89 score on a scale
Standard Deviation 11.59
|
46.25 score on a scale
Standard Deviation 9.84
|
52.38 score on a scale
Standard Deviation 7.87
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Mental health: 1-Year
|
50.17 score on a scale
Standard Deviation 10.24
|
48.26 score on a scale
Standard Deviation 10.38
|
46.45 score on a scale
Standard Deviation 11.58
|
54.23 score on a scale
Standard Deviation 6.40
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Physical limitation: 1-Year
|
71.98 score on a scale
Standard Deviation 16.65
|
68.80 score on a scale
Standard Deviation 17.83
|
66.61 score on a scale
Standard Deviation 17.39
|
76.30 score on a scale
Standard Deviation 10.77
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Angina stability: 1-Year
|
80.31 score on a scale
Standard Deviation 28.17
|
82.52 score on a scale
Standard Deviation 27.26
|
71.71 score on a scale
Standard Deviation 30.98
|
92.00 score on a scale
Standard Deviation 19.32
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Angina frequency: 1-Year
|
92.46 score on a scale
Standard Deviation 11.36
|
92.59 score on a scale
Standard Deviation 14.71
|
86.00 score on a scale
Standard Deviation 16.46
|
97.00 score on a scale
Standard Deviation 6.75
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Treatment satisfaction: 1-Year
|
87.40 score on a scale
Standard Deviation 17.89
|
86.85 score on a scale
Standard Deviation 20.74
|
84.90 score on a scale
Standard Deviation 18.42
|
97.65 score on a scale
Standard Deviation 3.04
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SAQ: Disease perception: 1-Year
|
79.03 score on a scale
Standard Deviation 20.16
|
77.58 score on a scale
Standard Deviation 21.77
|
71.04 score on a scale
Standard Deviation 23.64
|
91.67 score on a scale
Standard Deviation 13.61
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF-36: Phys comp: Baseline
|
45.41 score on a scale
Standard Deviation 9.27
|
46.07 score on a scale
Standard Deviation 9.69
|
46.10 score on a scale
Standard Deviation 8.51
|
47.2 score on a scale
Standard Deviation 9.19
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF-36: Phys Func: Baseline
|
46.41 score on a scale
Standard Deviation 10.48
|
47.16 score on a scale
Standard Deviation 9.98
|
46.4 score on a scale
Standard Deviation 9361
|
46.3 score on a scale
Standard Deviation 12.37
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF-36: Role-physical: Baseline
|
46.07 score on a scale
Standard Deviation 10.22
|
46.76 score on a scale
Standard Deviation 10.26
|
45.77 score on a scale
Standard Deviation 8.79
|
48.04 score on a scale
Standard Deviation 10.07
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Bodily pain: Baseline
|
45.83 score on a scale
Standard Deviation 9.11
|
45.87 score on a scale
Standard Deviation 8.72
|
46.31 score on a scale
Standard Deviation 7.94
|
45.55 score on a scale
Standard Deviation 9.65
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: General health: Baseline
|
47.10 score on a scale
Standard Deviation 9.01
|
46.43 score on a scale
Standard Deviation 9.51
|
46.17 score on a scale
Standard Deviation 8.13
|
50.31 score on a scale
Standard Deviation 5.08
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Mental comp: Baseline
|
49.42 score on a scale
Standard Deviation 11.15
|
48.52 score on a scale
Standard Deviation 10.64
|
47.09 score on a scale
Standard Deviation 9.55
|
49.46 score on a scale
Standard Deviation 6.91
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Vitality: Baseline
|
48.11 score on a scale
Standard Deviation 10.23
|
46.75 score on a scale
Standard Deviation 10.9
|
47.9 score on a scale
Standard Deviation 9.86
|
46.75 score on a scale
Standard Deviation 10.90
|
|
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36: Social functioning: Baseline
|
46.60 score on a scale
Standard Deviation 10.63
|
47.25 score on a scale
Standard Deviation 10.42
|
46.86 score on a scale
Standard Deviation 9.40
|
49.76 score on a scale
Standard Deviation 5.17
|
SECONDARY outcome
Timeframe: Baseline and 1 yearPopulation: The study was terminated before data to compute life years was collected SF-36 scores have been reported previously
International medical records will be used to determine mortality which may not be feasible at all participating international sites. Utilities will be based on Quality of Well Being scores converted from the SF-36 assessments The analysis will be performed assuming a societal perspective and lifetime time horizon
Outcome measures
Outcome data not reported
Adverse Events
Group A: CCTA Diagnostic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: SPECT MPI/ICA Diagnostic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director Clinical Research Administration
American College of Radiology
Phone: 215-574-3150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place