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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Angina Pectoris; Acute Coronary Syndrome; Unstable Angina
• Intervention / Treatment: Procedure: Coronary Computed Tomography Angiography; Procedure: Stress Nuclear Myocardial Perfusion Imaging

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 CTA; Coronary CT; 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; sestamibi; nuclear stress test; nuclear cardiology; nuclear perfusion imaging; dual-isotope stress test; thallium; myocardial perfusion imaging; gated SPECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coronary catheterization that does not lead to re-vascularization	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of Hospital Stay (time to discharge)	usually from hours to a few days (average about one day)
Non-fatal myocardial infarction	1 year
Death (all cause)	1 year
Post-test renal dysfunction	usually within a few days

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Albert Einstein College of Medicine; American Heart Association
• Investigators: Principal Investigator: Jeffrey M Levsky, MD, PhD, Montefiore Medical Center/Albert Einstein College of Medicine; Study Director: Linda B Haramati, MD, MS, Montefiore Medical Center/Albert Einstein College of Medicine

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.jcct.2009.05.006. Epub 2009 May 21.
• Levsky JM, Spevack DM, Travin MI, Menegus MA, Huang PW, Clark ET, Kim CW, Hirschhorn E, Freeman KD, Tobin JN, Haramati LB. Coronary Computed Tomography Angiography Versus Radionuclide Myocardial Perfusion Imaging in Patients With Chest Pain Admitted to Telemetry: A Randomized Trial. Ann Intern Med. 2015 Aug 4;163(3):174-83. doi: 10.7326/M14-2948.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 24, 2008
• First Submitted That Met QC Criteria: June 24, 2008
• First Posted (Estimate): June 26, 2008

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: coronary computed tomography angiography; stress myocardial perfusion imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Chest Pain; Acute Coronary Syndrome; Angina Pectoris; Angina, Unstable
• Other Study ID Numbers: MMC-07-07-197