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

This study has been completed.
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
Information provided by (Responsible Party):
Udo Hoffmann, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01084239
First received: January 7, 2010
Last updated: April 8, 2014
Last verified: April 2014
History of Changes
Results First Received: September 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina Pectoris
Intervention: Radiation: Cardiac Computed Tomography

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient enrollment began on April 23, 2010, and ended on January 30, 2012, at nine hospitals in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

 Period 1:   Randomization - Index Hospitalization
    Cardiac CT     Standard of Care  
STARTED     501     499  
COMPLETED     501     499  
NOT COMPLETED     0     0  

Period 2:   28-Day Follow-up
    Cardiac CT     Standard of Care  
STARTED     501 [1]   499  
COMPLETED     497     490  
NOT COMPLETED     4     9  
Lost to Follow-up                 4                 9  
[1] All 501 patients enrolled were evaluated for follow-up at 28 days.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Cardiac CT     Standard of Care     Total  
Number of Participants  
[units: participants]
 		  501     499     1000  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     433     440     873  
>=65 years     68     59     127  
Age  
[units: years]
Mean (Standard Deviation) 		  54  (8)     54  (8)     54  (8)  
Gender  
[units: participants]
 		     
Female     239     229     468  
Male     262     270     532  
Region of Enrollment  
[units: participants]
 		     
United States     501     499     1000  



  Outcome Measures
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1.  Primary:   Length of Hospital Stay   [ Time Frame: Duration of stay in the hospital during the initial visit ]
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2.  Secondary:   Time to Diagnosis   [ 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 ). ]
  Show Outcome Measure 2

3.  Secondary:   Healthcare Utilization   [ Time Frame: Duration of stay in the hospital during the initial visit ]
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4.  Secondary:   MACE   [ Time Frame: 72 hours after discharge up to 28 days after enrollment. ]
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5.  Secondary:   Cost-effectiveness   [ Time Frame: Duration of stay in the hospital during the initial visit ]
  Show Outcome Measure 5

6.  Secondary:   Rate of ED Discharge   [ Time Frame: Duration of stay in the hospital during the initial visit ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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).


  More Information
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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:  
Name/Title: Pearl Zakroysky
Organization: Massachusetts Genderal Hospital Biostatistics Center
phone: 617 724 0309
e-mail: pzakroysky@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Udo Hoffmann, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01084239     History of Changes
Other Study ID Numbers: 2009P002331
Study First Received: January 7, 2010
Results First Received: September 9, 2013
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board