Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

Phase 2

Completed

• Conditions: Chest Pain; Angina Pectoris; Myocardial Infarction

• Registration Number: NCT00273832
• Lead Sponsor: William Beaumont Hospitals

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-03
• Study Completion: 2005-11
• Status Verified: 2005-12
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Last Update Submitted: 2006-01-04
• Study First Posted: 2006-01-09
• Last Update Posted: 2006-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Length of stay
Cost of care

Secondary Outcome Measures

Name	Time	Method
Unstable angina within 90-days
Acute myocardial infarction within 90-days
Cardiac death within 90-days

Trial Locations

Locations (1)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States