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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American Heart Association
Albert Einstein College of Medicine of Yeshiva University
Information provided by (Responsible Party):
Jeffrey Levsky, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00705458
First received: June 24, 2008
Last updated: December 18, 2013
Last verified: December 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 400
Study Start Date: July 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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 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

Publications:
Responsible Party: Jeffrey Levsky, Associate Director of Research, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00705458     History of Changes
Other Study ID Numbers: MMC-07-07-197
Study First Received: June 24, 2008
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
stress myocardial perfusion imaging
coronary computed tomography angiography

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 23, 2014