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

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

This study is currently recruiting participants.

Verified by Montefiore Medical Center, September 2008

First Received: June 24, 2008 Last Updated: September 19, 2008 History of Changes

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

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

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

No publications provided

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

Arterial Occlusive Diseases
Disease
Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Arteriosclerosis
Chest Pain

Coronary Disease
Signs and Symptoms
Pathologic Processes
Syndrome
Acute Coronary Syndrome
Cardiovascular Diseases
Angina, Unstable
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 06, 2009