Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine whether coronary artery computed tomography scanning is a more rapid, less expensive and safe alternative to standard diagnostic evaluation of patients with acute chest pain in the emergency room.

Detailed Description
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Over 6 million patients per year visit hospital emergency departments for evaluation of chest pain, with diagnostic costs estimated to be in excess of $10 billion. Standard diagnostic evaluation often includes 8-12 hours of serial laboratory tests followed by stress imaging studies requiring an additional 4-8 hours. Multi-slice coronary artery computed tomography scanning (MSCT) has been shown to be a highly accurate diagnostic method in comparison to invasive angiography. Because of its speed and high negative predictive value, MSCT could rapidly screen patients for the presence of coronary disease, which may expedite their care. This study compares the length of stay and cost of care in emergency chest pain patients randomly assigned to initial evaluation by MSCT compared to patients randomly assigned to a standard diagnostic evaluation including single photon emission computed tomography scanning. The study follows these patients to detect major adverse cardiac events including unstable angina, acute myocardial infarction or death over a 90-day period.

Official Title
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Randomized Controlled Trial of Multi-Slice Coronary Computed Tomography for Evaluation of Acute Chest Pain

Conditions
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Chest Pain, Angina Pectoris, Myocardial Infarction

Intervention / Treatment
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* Procedure: coronary artery computed tomography angiogram
* Procedure: single photon emission computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chest pain or angina equivalent symptoms. Age ≥ 25 years. Low risk of infarction and/or complications by Goldman/Reilly criteria. Exclusion Criteria: Known coronary artery disease. Electrocardiogram diagnostic of acute cardiac ischemia and/or infarction. Elevated serum biomarkers including creatine kinase (CK) MB, myoglobin, and/or cardiac troponin I on initial testing. Contraindication to iodinated contrast and/or beta blocking drugs. Atrial fibrillation or markedly irregular rhythm. Pregnancy. Renal insufficiency, creatinine > 1.5 mg/dL. Iodinated contrast within prior 48 hours.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: coronary artery computed tomography angiogram|nan|
|Procedure: single photon emission computed tomography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  |  | 
| Cost of care |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unstable angina within 90-days |  |  | 
| Acute myocardial infarction within 90-days |  |  | 
| Cardiac death within 90-days |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest pain, Angina pectoris, Emergency medicine, Spiral computed tomography, Length of stay, Cost analysis