Trial Outcomes & Findings for Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography (NCT NCT01084239)
NCT ID: NCT01084239
Last Updated: 2014-05-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1000 participants
Primary outcome timeframe
Duration of stay in the hospital during the initial visit
Results posted on
2014-05-07
Participant Flow
Patient enrollment began on April 23, 2010, and ended on January 30, 2012, at nine hospitals in the United States.
Participant milestones
| Measure |
Cardiac CT
Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
Randomization - Index Hospitalization
STARTED
|
501
|
499
|
|
Randomization - Index Hospitalization
COMPLETED
|
501
|
499
|
|
Randomization - Index Hospitalization
NOT COMPLETED
|
0
|
0
|
|
28-Day Follow-up
STARTED
|
501
|
499
|
|
28-Day Follow-up
COMPLETED
|
497
|
490
|
|
28-Day Follow-up
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Cardiac CT
Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
28-Day Follow-up
Lost to Follow-up
|
4
|
9
|
Baseline Characteristics
Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography
Baseline characteristics by cohort
| Measure |
Cardiac CT
n=501 Participants
Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
n=499 Participants
Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
433 Participants
n=5 Participants
|
440 Participants
n=7 Participants
|
873 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
68 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 8 • n=5 Participants
|
54 years
STANDARD_DEVIATION 8 • n=7 Participants
|
54 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
239 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
468 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
262 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
532 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
501 participants
n=5 Participants
|
499 participants
n=7 Participants
|
1000 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of stay in the hospital during the initial visitOutcome measures
| Measure |
Cardiac CT
n=501 Participants
Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
n=499 Participants
Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
Length of Hospital Stay
|
23.2 hours
Standard Deviation 37.0
|
30.8 hours
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: Time from ED arrival to first positive test (all tests except Echocardiography Rest and including troponins ) if discharge diagnosis is ACS, otherwise time to performance of last test (all tests except Echocardiography Rest and including troponins ).Outcome measures
| Measure |
Cardiac CT
n=501 Participants
Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
n=499 Participants
Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
Time to Diagnosis
|
10.4 hours
Standard Deviation 12.6
|
18.7 hours
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Duration of stay in the hospital during the initial visitNumber of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)
Outcome measures
| Measure |
Cardiac CT
n=501 Participants
Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
n=499 Participants
Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
Healthcare Utilization
|
492 participants
|
390 participants
|
SECONDARY outcome
Timeframe: 72 hours after discharge up to 28 days after enrollment.Major Adverse Cardiovascular Events, All though these events are called MACE they do not qualify as adverse or serious adverse events. As these events are expected in some individuals in this population. Only MACE that occured within 72 hours after hospital discharge were considered serious adverse events in this trial. There were no such events.
Outcome measures
| Measure |
Cardiac CT
n=501 Participants
Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
n=499 Participants
Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
MACE
|
6 events
|
2 events
|
SECONDARY outcome
Timeframe: Duration of stay in the hospital during the initial visitTotal cost during index hospitalization
Outcome measures
| Measure |
Cardiac CT
n=501 Participants
Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
n=499 Participants
Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
Cost-effectiveness
|
4026 US Dollars
Standard Deviation 6792
|
3874 US Dollars
Standard Deviation 5298
|
SECONDARY outcome
Timeframe: Duration of stay in the hospital during the initial visitDirect discharge from Emergency Department
Outcome measures
| Measure |
Cardiac CT
n=501 Participants
Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
n=499 Participants
Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
Rate of ED Discharge
|
233 participants
|
62 participants
|
Adverse Events
Cardiac CT
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cardiac CT
n=501 participants at risk
Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
|
Standard of Care
n=499 participants at risk
Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
|
|---|---|---|
|
General disorders
Nausea and vomiting
|
0.20%
1/501 • Number of events 1
|
0.00%
0/499
|
|
General disorders
Nausea
|
0.20%
1/501 • Number of events 1
|
0.00%
0/499
|
|
Eye disorders
RASH URTICARIAL
|
0.20%
1/501 • Number of events 1
|
0.00%
0/499
|
|
General disorders
ALLERGIC REACTION
|
0.40%
2/501 • Number of events 2
|
0.00%
0/499
|
|
General disorders
THROMBOSIS ARTERIAL
|
0.00%
0/501
|
0.20%
1/499 • Number of events 1
|
Additional Information
Pearl Zakroysky
Massachusetts Genderal Hospital Biostatistics Center
Phone: 617 724 0309
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place