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Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00273832
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : January 9, 2006
The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chest Pain Angina Pectoris Myocardial Infarction Procedure: coronary artery computed tomography angiogram Procedure: single photon emission computed tomography Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial of Multi-Slice Coronary Computed Tomography for Evaluation of Acute Chest Pain
Study Start Date : March 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Length of stay
  2. Cost of care

Secondary Outcome Measures :
  1. Unstable angina within 90-days
  2. Acute myocardial infarction within 90-days
  3. Cardiac death within 90-days

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00273832

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United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan
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Principal Investigator: Gilbert L Raff, MD William Beaumont Hospitals

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00273832     History of Changes
Other Study ID Numbers: HIC – 2005 – 010
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: January 9, 2006
Last Verified: December 2005

Keywords provided by William Beaumont Hospitals:
Chest pain
Angina pectoris
Emergency medicine
Spiral computed tomography
Length of stay
Cost analysis

Additional relevant MeSH terms:
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Myocardial Infarction
Angina Pectoris
Chest Pain
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms