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

June 24, 2008
December 18, 2013
July 2008
March 2013   (final data collection date for primary outcome measure)
Coronary catheterization that does not lead to re-vascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00705458 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized for Chest Pain
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Coronary Artery Disease
  • Angina Pectoris
  • Unstable Angina
  • Acute Coronary Syndrome
  • 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
  • Experimental: CTA
    Initial EKG-gated computed tomography angiography of the coronary arteries
    Intervention: Procedure: Coronary Computed Tomography Angiography
  • Active Comparator: MPI
    Initial nuclear stress myocardial perfusion imaging
    Intervention: Procedure: Stress Nuclear Myocardial Perfusion Imaging
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
December 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00705458
MMC-07-07-197
Yes
Jeffrey Levsky, Montefiore Medical Center
Montefiore Medical Center
  • American Heart Association
  • Albert Einstein College of Medicine of Yeshiva University
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
Montefiore Medical Center
December 2013

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