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Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00273832
Enrollment
200
Registered
2006-01-09
Start date
2005-03-31
Completion date
2005-11-30
Last updated
2006-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Chest Pain, Myocardial Infarction

Keywords

Chest pain, Angina pectoris, Emergency medicine, Spiral computed tomography, Length of stay, Cost analysis

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.

Interventions

PROCEDUREcoronary artery computed tomography angiogram
PROCEDUREsingle photon emission computed tomography

Sponsors

The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan
CollaboratorUNKNOWN
Corewell Health East
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Length of stay
Cost of care

Secondary

MeasureTime frame
Unstable angina within 90-days
Acute myocardial infarction within 90-days
Cardiac death within 90-days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026