Rule Out Myocardial Infarction by Computer Assisted Tomography (ROMICAT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00990262 |
Recruitment Status :
Completed
First Posted : October 6, 2009
Last Update Posted : October 6, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris | Radiation: Cardiac Computed Tomography |
Study Type : | Observational |
Actual Enrollment : | 368 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Accuracy of Contrast Enhanced Multidetector Computed Tomography to Identify Cardiac Cause of Symptoms in Patients With Intermediate Likelihood of Acute Coronary Syndrome (ACS) - A Comparison to Standard Care |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | April 2009 |

Group/Cohort | Intervention/treatment |
---|---|
Acute Chest Pain
Patients who presented to the emergency department with acute chest pain, with negative initial biomarkers and normal or non-ischemic ECG
|
Radiation: Cardiac Computed Tomography
|
- Accuracy of CT derived features of coronary artery disease and LV function for ACS [ Time Frame: ED presentation to hospital discharge ]
- Major adverse cardiac events (MACE) - defined as death, myocardial infarction or coronary revascularization [ Time Frame: Follow up at 6 months and 2 year after index hospitalization ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with any episode > five minutes of chest pain being admitted to rule out acute coronary syndrome
Exclusion Criteria:
- Positive initial troponin or CK-MB tests
- Diagnostic ECG changes (ST- segment elevation or horizontal ST- segment depression in more than two contiguous leads)
- Unstable clinical condition (hemodynamically unstable, ventricular tachycardia, persistent chest pain despite adequate therapy)
- Creatinine Clearance <50 mL/min
- Known allergy to iodinated contrast agents
- Patients on metformin therapy unable or unwilling to discontinue therapy for 48 hours after CT scan procedure
- Known asthma, reactive airway disease
- Patients currently in atrial fibrillation
- Previous intolerance to beta blocker
- Patients that are referred for coronary angiography/PCI by their PCP or cardiologist.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990262
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Udo Hoffmann, MD, MPH | Massachusetts General Hospital |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Udo Hoffmann, MD MPH, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00990262 |
Other Study ID Numbers: |
2003P000458 R01HL080053-01 ( U.S. NIH Grant/Contract ) |
First Posted: | October 6, 2009 Key Record Dates |
Last Update Posted: | October 6, 2009 |
Last Verified: | October 2009 |
acute chest pain emergency department cardiac computed tomography |
Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Angina, Unstable Syndrome Infarction Disease Pathologic Processes Ischemia |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Neurologic Manifestations |