Official Title: “A Randomized Trial Comparing Multi-Detector Coronary CT Angiography and Stress Myocardial Perfusion Imaging as the Initial Test for the Diagnosis of Coronary Artery Disease in Intermediate Risk Patients Admitted for Chest Pain”

The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2011

Intervention(s) in this Clinical Trial

• Procedure: Coronary Computed Tomography Angiography
  • 64-detector, retrospectively EKG-gated, computed tomography angiography of the coronary arteries during heart rate control (intravenous metoprolol, when necessary)
• Procedure: Stress Nuclear Myocardial Perfusion Imaging
  • Usually dual-isotope perfusion imaging at rest (201-Thallium) and at stress (99m-Technetium-MIBI). Some patients will have a 2-day MIBI protocol. Gated SPECT and attenuation-correction images will be obtained. Treadmill stress will be performed. If a patient is unable to exercise, adenosine or dobutamine will be given.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: CTA
  • Initial EKG-gated computed tomography angiography of the coronary arteries
• Active Comparator: MPI
  • Initial nuclear stress myocardial perfusion imaging

Primary Measures

• Coronary catheterization that does not lead to re-vascularization
  • Time Frame: 1 year
    Safety Issue?: Yes

Secondary Measures

• Length of Hospital Stay (time to discharge)
  • Time Frame: hosptial discharge
    Safety Issue?: No
• Non-fatal myocardial infarction
  • Time Frame: 1 year
    Safety Issue?: Yes
• Death (all cause)
  • Time Frame: 1 year
    Safety Issue?: Yes
• Post-test renal dysfunction
  • Time Frame: hospital discharge
    Safety Issue?: Yes

Inclusion Criteria:

• patient admitted for chest pain or pressure
• patient at intermediate short term risk of MI or death (AHA/ACC guidelines)

Exclusion Criteria:

• prior diagnosis of coronary artery disease
• evidence of ongoing myocardial infarction (and other high risk criteria per AHA/ACC guidelines)
• contraindications to EKG-gated CT scanning with iodinated intravenous contrast under beta-blockade
• pregnancy
• presence of an implanted pacemaker or defibrillator
• stress myocardial perfusion imaging, coronary CTA or coronary catheterization within the last 6 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Montefiore Medical Center

Overall Clinical Trial Officials and Contacts

Linda B Haramati, MD, MS Study Director Montefiore Medical Center / Albert Einstein College of Medicine  

Overall Contact: Linda B Haramati, MD, MS 718-920-7458 lharamati@aecom.yu.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00705458

Study ID Number: MMC-07-07-197

ClinicalTrials.gov Identifier: NCT00705458

Health Authority: United States: Institutional Review Board