Viewing Study NCT00990262



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Study NCT ID: NCT00990262
Status: COMPLETED
Last Update Posted: 2009-10-06
First Post: 2009-09-30

Brief Title: Rule Out Myocardial Infarction by Computer Assisted Tomography
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

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
Status: COMPLETED
Status Verified Date: 2009-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ROMICAT
Brief Summary: 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 56 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 ie 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL080053-01 NIH None httpsreporternihgovquickSearchR01HL080053-01