Rule Out Myocardial Infarction by Computer Assisted Tomography (ROMICAT)

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00990262
First received: September 30, 2009
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina Pectoris
Radiation: Cardiac Computed Tomography

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Accuracy of CT derived features of coronary artery disease and LV function for ACS [ Time Frame: ED presentation to hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Plasma


Enrollment: 368
Study Start Date: May 2005
Study Completion Date: April 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00990262

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Udo Hoffmann, MD, MPH Massachusetts General Hospital
  More Information

Publications:

Additional 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     History of Changes
Other Study ID Numbers: 2003P000458, R01 HL080053-01
Study First Received: September 30, 2009
Last Updated: October 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
acute chest pain
emergency department
cardiac computed tomography

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 24, 2014