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
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Study Type | Interventional |
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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 |
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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.
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Arm/Group Title | Cardiac CT | Standard of Care | Total | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 501 participants | 499 participants | 1000 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
433 86.4%
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440 88.2%
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873 87.3%
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>=65 years |
68 13.6%
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59 11.8%
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127 12.7%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 501 participants | 499 participants | 1000 participants | |
Female |
239 47.7%
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229 45.9%
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468 46.8%
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Male |
262 52.3%
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270 54.1%
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532 53.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 501 participants | 499 participants | 1000 participants |
501 | 499 | 1000 |
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).
Name/Title: | Pearl Zakroysky |
Organization: | Massachusetts Genderal Hospital Biostatistics Center |
Phone: | 617 724 0309 |
EMail: | pzakroysky@partners.org |
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 |