Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

This study has been completed.
Sponsor:
Collaborator:
The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00273832
First received: January 4, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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 Intervention Phase
Chest Pain
Angina Pectoris
Myocardial Infarction
Procedure: coronary artery computed tomography angiogram
Procedure: single photon emission computed tomography
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial of Multi-Slice Coronary Computed Tomography for Evaluation of Acute Chest Pain

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Length of stay
  • Cost of care

Secondary Outcome Measures:
  • Unstable angina within 90-days
  • Acute myocardial infarction within 90-days
  • Cardiac death within 90-days

Estimated Enrollment: 200
Study Start Date: March 2005
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273832

Locations
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
Investigators
Principal Investigator: Gilbert L Raff, MD William Beaumont Hospitals
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00273832     History of Changes
Other Study ID Numbers: HIC – 2005 – 010
Study First Received: January 4, 2006
Last Updated: January 4, 2006
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014