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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00705458
Recruitment Status : Completed
First Posted : June 26, 2008
Last Update Posted : August 25, 2015
Sponsor:
Collaborators:
American Heart Association
Albert Einstein College of Medicine
Information provided by (Responsible Party):
Jeffrey Levsky, Montefiore Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Angina Pectoris Unstable Angina Acute Coronary Syndrome Procedure: Coronary Computed Tomography Angiography Procedure: Stress Nuclear Myocardial Perfusion Imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : July 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CTA
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)
Other Names:
  • CCTA
  • Coronary CT
  • Coronary CTA
  • Coronary Artery CT
  • Coronary Artery CTA
  • Coronary CT Angiography
  • CTA of the Coronary Arteries
Active Comparator: MPI
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.
Other Names:
  • stress test
  • nuclear stress test
  • dual-isotope stress test
  • sestamibi
  • thallium
  • myocardial perfusion imaging
  • nuclear perfusion imaging
  • gated SPECT
  • nuclear cardiology


Outcome Measures
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Primary Outcome Measures :
  1. Coronary catheterization that does not lead to re-vascularization [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Length of Hospital Stay (time to discharge) [ Time Frame: usually from hours to a few days (average about one day) ]
  2. Non-fatal myocardial infarction [ Time Frame: 1 year ]
  3. Death (all cause) [ Time Frame: 1 year ]
  4. Post-test renal dysfunction [ Time Frame: usually within a few days ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705458


Locations
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United States, New York
Moses Division, Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
American Heart Association
Albert Einstein College of Medicine
Investigators
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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
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Publications of Results:

Other Publications:

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Responsible Party: Jeffrey Levsky, Associate Director of Research, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00705458    
Other Study ID Numbers: MMC-07-07-197
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015
Keywords provided by Jeffrey Levsky, Montefiore Medical Center:
stress myocardial perfusion imaging
coronary computed tomography angiography
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Angina Pectoris
Angina, Unstable
Chest Pain
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations