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Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

William Beaumont Hospitals logo

William Beaumont Hospitals

Status and phase

Completed
Phase 2

Conditions

Angina Pectoris
Chest Pain
Myocardial Infarction

Treatments

Procedure: coronary artery computed tomography angiogram
Procedure: single photon emission computed tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT00273832
HIC - 2005 - 010

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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