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

Purpose

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.

Condition	Intervention
Coronary Artery Disease Angina Pectoris Unstable Angina Acute Coronary Syndrome	Procedure: Coronary Computed Tomography Angiography Procedure: Stress Nuclear Myocardial Perfusion Imaging

MedlinePlus related topics:

Angina CT Scans Chest Pain Coronary Artery Disease Nuclear Scans Stress

ChemIDplus related topics:

Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate Adenosine

U.S. FDA Resources

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

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

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CTA: Experimental Initial EKG-gated computed tomography angiography of the coronary arteries	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)
MPI: Active Comparator Initial nuclear stress myocardial perfusion imaging	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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705458

Contacts


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

Locations


United States, New York
	Moses Division, Montefiore Medical Center	Recruiting
	Bronx, New York, United States, 10467

Sponsors and Collaborators

Montefiore Medical Center

American Heart Association

Albert Einstein College of Medicine of Yeshiva University

Investigators


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

More Information

Responsible Party:	Montefiore Medical Center ( Linda B. Haramati, MD, MS / Division Chief of Cardiothoracic Radiology )
Study ID Numbers:	MMC-07-07-197
First Received:	June 24, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00705458
Health Authority:	United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:

stress myocardial perfusion imaging

coronary computed tomography angiography

Study placed in the following topic categories:

Arterial Occlusive Diseases

Heart Diseases

Myocardial Ischemia

Angina Pectoris

Vascular Diseases

Stress

Pain

Arteriosclerosis

Ischemia

Metoprolol

Dobutamine

Chest Pain

Coronary Disease

Signs and Symptoms

Metoprolol succinate

Acute Coronary Syndrome

Adenosine

Angina, Unstable

Coronary Artery Disease

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	Montefiore Medical Center American Heart Association Albert Einstein College of Medicine of Yeshiva University
Information provided by:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00705458