Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized for Chest Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

June 24, 2008

Last Updated Date

October 27, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Coronary catheterization that does not lead to re-vascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00705458 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Length of Hospital Stay (time to discharge) [ Time Frame: hosptial discharge ] [ Designated as safety issue: No ]
Non-fatal myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Death (all cause) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Post-test renal dysfunction [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized for Chest Pain

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Diagnostic

Condition ^ICMJE

Coronary Artery Disease
Angina Pectoris
Unstable Angina
Acute Coronary Syndrome

Intervention ^ICMJE

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)
Other Names:
- CCTA
- Coronary CT
- Coronary CTA
- Coronary Artery CT
- Coronary Artery CTA
- Coronary CT Angiography
- CTA of the Coronary Arteries
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.
Other Names:
- stress test
- nuclear stress test
- dual-isotope stress test
- sestamibi
- thallium
- myocardial perfusion imaging
- nuclear perfusion imaging
- gated SPECT
- nuclear cardiology

Study Arms / Comparison Groups

CTA: Experimental
Initial EKG-gated computed tomography angiography of the coronary arteries

Intervention: Procedure: Coronary Computed Tomography Angiography
MPI: Active Comparator
Initial nuclear stress myocardial perfusion imaging

Intervention: Procedure: Stress Nuclear Myocardial Perfusion Imaging

Publications *

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.

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

June 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Linda B Haramati, MD, MS

718-920-7458

lharamati@aecom.yu.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00705458

Responsible Party

Linda B. Haramati, MD, MS / Division Chief of Cardiothoracic Radiology, Montefiore Medical Center

Study ID Numbers ^ICMJE

MMC-07-07-197

Study Sponsor ^ICMJE

Montefiore Medical Center

Collaborators ^ICMJE

American Heart Association
Albert Einstein College of Medicine of Yeshiva University

Investigators ^ICMJE

Study Director:	Linda B Haramati, MD, MS	Montefiore Medical Center / Albert Einstein College of Medicine
Principal Investigator:	Jeffrey M Levsky, MD, PhD	Montefiore Medical Center / Albert Einstein College of Medicine

Information Provided By

Montefiore Medical Center

Verification Date

October 2009

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