Rule Out Myocardial Infarction by Computer Assisted Tomography (ROMICAT)

October 2, 2009 updated by: Massachusetts General Hospital

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

The goal of this research is to determine noninvasively whether detection of coronary stenosis and plaque by multidetector computed tomography (MDCT) in patients with acute chest pain suspected of acute coronary syndrome (ACS) enhances triage, reduces cost and is cost effective. Among the 5.6 million patients with ACP presenting annually in emergency departments (ED) in the United States, a subgroup of two million patients is hospitalized despite normal initial cardiac biomarker tests and electrocardiogram (ECG). This subgroup is at low (20%) risk for ACS during the index hospitalization. Most (80-94%) patients with a diagnosis of ACS have a significant epicardial coronary artery stenosis ( >50% luminal narrowing). However, in -10% of patients non-stenotic coronary plaque triggers events, i.e. vasospasms, leading to myocardial ischemia. Since the absence of plaque excludes a coronary cause of chest pain, these patients could in theory be discharged earlier reducing unnecessary hospital admissions. Recent publications demonstrate high sensitivity and specificity of MDCT for the detection of significant coronary stenosis compared with coronary angiography and the detection of coronary plaque as validated with intravascular ultrasound. Using 64- slice MDCT we propose to study 400 patients with ACP, negative initial cardiac biomarkers and non-diagnostic ECG. We will analyze MDCT images for the presence of significant coronary artery stenosis and plaque and correlate the data with the clinical diagnosis of ACS (AHA guidelines) during the index hospitalization to determine the sensitivity and specificity. MDCT data, risk factors, and the results of standard diagnostic tests available at the time of MDCT will be used to generate a multivariate prediction function and derive a clinical decision rule. Based on this decision rule we will compare the diagnostic accuracies and cost effectiveness of competing strategies. We hypothesize that an MDCT- based diagnostic strategy will reduce the time to diagnosis of ACS, number of hospitalizations, and absolute cost of management of patients with acute chest pain compared to standard clinical care and is cost effective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

368

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who presented to the emergency department at Massachusetts General Hospital, with acute chest pain and with initial negative biomarkers and normal or non-ischemic ECG

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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
  1. Localization of the heart position in a projectional topographic scan of the chest.
  2. Determination of contrast agent transit time: 10 ml contrast agent.
  3. CT coronary angiography: CT scan in spiral acquisition mode with 330 ms rotation time, 32 x 0.6 mm collimation, a pitch of 2.8 mm/rotation, tube voltage of 120 kVp, and maximum tube current of 850 mA. 80 ml of contrast agent, followed by 40 ml saline solution will be injected at a rate of 4 ml/s. The mean breath hold duration for this acquisition is approximately 13 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of CT derived features of coronary artery disease and LV function for ACS
Time Frame: ED presentation to hospital discharge
ED presentation to hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Follow up at 6 months and 2 year after index hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Udo Hoffmann, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

October 2, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003P000458
  • R01HL080053-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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