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OpenTrials
Completed

NCT Number: NCT00273832

Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

coronary artery computed tomography angiogram

Procedure

Single Photon Emission Computed Tomography

Procedure

Primary outcomes

  1. Length of stay

  2. Cost of care

Secondary outcomes

  1. Unstable angina within 90-days

  2. Acute myocardial infarction within 90-days

  3. Cardiac death within 90-days

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Collaborators

  • The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Jan 9, 2006
Registry last updated
Jan 9, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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