Trial record 1 of 2 for:    ROMICAT
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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

September 30, 2009
October 2, 2009
May 2005
May 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00990262 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Rule Out Myocardial Infarction by Computer Assisted Tomography
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma

Non-Probability Sample

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

  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Unstable Angina Pectoris
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.
Acute Chest Pain
Patients who presented to the emergency department with acute chest pain, with negative initial biomarkers and normal or non-ischemic ECG
Intervention: Radiation: Cardiac Computed Tomography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
368
April 2009
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00990262
2003P000458, R01 HL080053-01
No
Udo Hoffmann, MD MPH, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Udo Hoffmann, MD, MPH Massachusetts General Hospital
Massachusetts General Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP