Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- Study Primary Completion Date: June 2012
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
Outcome Measures for this Clinical Trial
Primary Measures
- Coronary catheterization that does not lead to re-vascularization
- Time Frame: 1 year
Safety Issue?: Yes
- Time Frame: 1 year
Secondary Measures
- Length of Hospital Stay (time to discharge)
- Time Frame: hosptial discharge
Safety Issue?: No
- Time Frame: hosptial discharge
- Non-fatal myocardial infarction
- Time Frame: 1 year
Safety Issue?: Yes
- Time Frame: 1 year
- Death (all cause)
- Time Frame: 1 year
Safety Issue?: Yes
- Time Frame: 1 year
- Post-test renal dysfunction
- Time Frame: hospital discharge
Safety Issue?: Yes
- Time Frame: hospital discharge
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Montefiore Medical Center Other
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
Related Publications
References
Levsky JM, Travin MI, Spevack DM, Menegus MA, Huang PW, Goldberg Y, Clark ET, Banoth P, Freeman KD, Tobin JN, Haramati LB. Rationale and design of a randomized controlled trial comparing stress myocardial perfusion imaging with coronary CT angiography as the initial imaging study for intermediate-risk patients admitted with chest pain. J Cardiovasc Comput Tomogr. 2009 Jul-Aug;3(4):264-71. Epub 2009 May 21.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00705458
