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Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain
This study has been completed.
Study NCT00273832   Information provided by William Beaumont Hospitals
First Received: January 4, 2006   No Changes Posted

January 4, 2006
January 4, 2006
March 2005
 
  • Length of stay
  • Cost of care
Same as current
No Changes Posted
  • Unstable angina within 90-days
  • Acute myocardial infarction within 90-days
  • Cardiac death within 90-days
Same as current
 
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

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.

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.

Phase II
Interventional
Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
  • Chest Pain
  • Angina Pectoris
  • Myocardial Infarction
  • Procedure: coronary artery computed tomography angiogram
  • Procedure: single photon emission computed tomography
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
200
November 2005
 

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.
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00273832
 
HIC – 2005 – 010
William Beaumont Hospitals
The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan
Principal Investigator: Gilbert L Raff, MD William Beaumont Hospitals
William Beaumont Hospitals
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP