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NCT00990262 · ClinicalTrials.gov registry record
Rule Out Myocardial Infarction by Computer Assisted Tomography
A clinical trial of Myocardial Infarction and Acute Coronary Syndrome, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 368
- Enrollment target
- 1
- Study location
NCT00990262 is a study of Myocardial Infarction and Acute Coronary Syndrome that has completed, run by Massachusetts General Hospital. The registered enrollment target is 368 participants, below the 4,676-participant average among 64 other Myocardial Infarction trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00990262, a study of Myocardial Infarction and Acute Coronary Syndrome, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 368 participants
- Enrollment target
- 1
- Study location
Study 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 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 wi
Conditions Studied
Interventions
- RADIATION Cardiac Computed Tomography
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00990262
The ClinicalTrials.gov registry entry for NCT00990262 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 368 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,676-participant average among 64 other Myocardial Infarction trials with a reported enrollment target (92% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Myocardial Infarction appearing as the primary indexed condition, and to 1 intervention - of which Cardiac Computed Tomography is the first listed.
NCT00990262 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00990262 about?
NCT00990262 is a clinical study titled "Rule Out Myocardial Infarction by Computer Assisted Tomography". 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 millio...
What is the current status of trial NCT00990262?
This trial is currently completed. The enrollment target is 368 participants. The study started on 2005-05. Estimated completion is 2009-04.
What conditions does trial NCT00990262 study?
This clinical trial studies the following conditions: Myocardial Infarction, Acute Coronary Syndrome, Unstable Angina Pectoris.
What interventions are being tested in trial NCT00990262?
The interventions under investigation include: Cardiac Computed Tomography (RADIATION).
Who is sponsoring clinical trial NCT00990262?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00990262 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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