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Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography (ROMICAT-II)

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ClinicalTrials.gov Identifier: NCT01084239
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Kaiser Permanente
Beth Israel Deaconess Medical Center
Bay State Clinical Trials, Inc.
Washington University School of Medicine
Tufts Medical Center
The Cleveland Clinic
Northwestern University
University of Maryland, College Park
Information provided by (Responsible Party):
Udo Hoffmann, MD MPH, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina Pectoris
Intervention Radiation: Cardiac Computed Tomography
Enrollment 1000
Recruitment Details Patient enrollment began on April 23, 2010, and ended on January 30, 2012, at nine hospitals in the United States.
Pre-assignment Details  
Arm/Group Title Cardiac CT Standard of Care
Hide Arm/Group Description

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.

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.
Period Title: Randomization - Index Hospitalization
Started 501 499
Completed 501 499
Not Completed 0 0
Period Title: 28-Day Follow-up
Started 501 [1] 499
Completed 497 490
Not Completed 4 9
Reason Not Completed
Lost to Follow-up             4             9
[1]
All 501 patients enrolled were evaluated for follow-up at 28 days.
Arm/Group Title Cardiac CT Standard of Care Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 501 499 1000
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants 499 participants 1000 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
433
  86.4%
440
  88.2%
873
  87.3%
>=65 years
68
  13.6%
59
  11.8%
127
  12.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 501 participants 499 participants 1000 participants
54  (8) 54  (8) 54  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants 499 participants 1000 participants
Female
239
  47.7%
229
  45.9%
468
  46.8%
Male
262
  52.3%
270
  54.1%
532
  53.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 501 participants 499 participants 1000 participants
501 499 1000
1.Primary Outcome
Title Length of Hospital Stay
Hide Description [Not Specified]
Time Frame Duration of stay in the hospital during the initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac CT Standard of Care
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 501 499
Mean (Standard Deviation)
Unit of Measure: hours
23.2  (37.0) 30.8  (28.0)
2.Secondary Outcome
Title Time to Diagnosis
Hide Description [Not Specified]
Time Frame 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 ).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac CT Standard of Care
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 501 499
Mean (Standard Deviation)
Unit of Measure: hours
10.4  (12.6) 18.7  (11.8)
3.Secondary Outcome
Title Healthcare Utilization
Hide Description Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)
Time Frame Duration of stay in the hospital during the initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac CT Standard of Care
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 501 499
Measure Type: Number
Unit of Measure: participants
492 390
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cardiac CT, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments Result for index hospitalization
4.Secondary Outcome
Title MACE
Hide Description 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.
Time Frame 72 hours after discharge up to 28 days after enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac CT Standard of Care
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 501 499
Measure Type: Number
Unit of Measure: events
6 2
5.Secondary Outcome
Title Cost-effectiveness
Hide Description Total cost during index hospitalization
Time Frame Duration of stay in the hospital during the initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac CT Standard of Care
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 501 499
Mean (Standard Deviation)
Unit of Measure: US Dollars
4026  (6792) 3874  (5298)
6.Secondary Outcome
Title Rate of ED Discharge
Hide Description Direct discharge from Emergency Department
Time Frame Duration of stay in the hospital during the initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac CT Standard of Care
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 501 499
Measure Type: Number
Unit of Measure: participants
233 62
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cardiac CT Standard of Care
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Cardiac CT Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Cardiac CT Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/501 (0.00%)      0/499 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cardiac CT Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/501 (1.00%)      1/499 (0.20%)    
Eye disorders     
RASH URTICARIAL * [1]  1/501 (0.20%)  1 0/499 (0.00%)  0
General disorders     
Nausea and vomiting * [2]  1/501 (0.20%)  1 0/499 (0.00%)  0
Nausea * [3]  1/501 (0.20%)  1 0/499 (0.00%)  0
ALLERGIC REACTION *  2/501 (0.40%)  2 0/499 (0.00%)  0
THROMBOSIS ARTERIAL * [4]  0/501 (0.00%)  0 1/499 (0.20%)  1
*
Indicates events were collected by non-systematic assessment
[1]
The patient developed a mild urticarial rash (2 separate quarter sized patches, 1 superior-lateral to his right eye and 1 superior-medial to his left eye) and associated itchiness within minutes of the injection of IV contrast.
[2]
one episode N/V after CTA contrast. Pt given 4mg zofran IV, symptoms resolved.
[3]
Patient developed nausea immediately after administration of IV contrast, she has had IV contrast in the past without associated nausea.
[4]
right groin pseudoaneurysm

Enrollment occurred only during weekday hours.

Lack of blinding to the intervention.

Results may not be applicable to populations we did not study (i.e. patients younger than 40 years of age and those older than 74 years of age).

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pearl Zakroysky
Organization: Massachusetts Genderal Hospital Biostatistics Center
Phone: 617 724 0309
EMail: pzakroysky@partners.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Udo Hoffmann, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01084239    
Other Study ID Numbers: 2009P002331
First Submitted: January 7, 2010
First Posted: March 10, 2010
Results First Submitted: September 9, 2013
Results First Posted: May 7, 2014
Last Update Posted: May 7, 2014