Study Comparing CT Scan and Stress Test in Patients With Known Coronary Artery Disease Hospitalized for Chest Pain (PROSPECT-CAD)

April 7, 2015 updated by: Jeffrey Levsky, Montefiore Medical Center

A Randomized Controlled Trial Comparing Coronary CT Angiography and Radionuclide Stress Myocardial Perfusion Imaging in Symptomatic Inpatients With Known Coronary Artery Disease

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 known coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 / pressure or other suggestive symptoms
  • patient has known coronary artery disease (with or without prior revascularization)
  • patient has clinical need for non-invasive cardiac evaluation

Exclusion Criteria:

  • evidence of ongoing myocardial infarction or hemodynamic instability
  • ischemia on EKG (greater than 1mm ST segment deviation)
  • contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction)
  • heart rhythm precluding EKG gating
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Initial coronary CT angiography
EKG-gated, computed tomography angiography of the coronary arteries during heart rate control
Procedure: Coronary CT angiography
EKG-gated, computed tomography angiography of the coronary arteries during heart rate control
Other Names:
  • Cardiac CT
  • CTA
  • CCTA
  • Coronary CTA
  • Coronary CT
  • CTA of the coronary arteries
  • CT of the coronary arteries
  • Cardiac CTA
  • CT Angiography of the coronary arteries
  • Computed tomography angiography of the coronary arteries
Active Comparator: Initial nuclear stress test
Stress radionuclide myocardial perfusion imaging
Procedure: Myocardial perfusion imaging
Stress radionuclide myocardial perfusion imaging
Other Names:
  • MPS
  • MPI
  • stress MPI
  • stress MPS
  • radionuclide MPI
  • stress nuclear
  • nuclear stress
  • nuclear stress test
  • nuclear stress testing
  • nuclear cardiology
  • nuclear perfusion imaging
  • nuclear myocardial perfusion imaging
  • myocardial perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay (time to discharge)
Time Frame: 1 month
1 month
Number of participants that have a subsequent non-fatal myocardial infarction
Time Frame: 1 year
1 year
Number of participants that die due to any cause
Time Frame: 1 year
1 year
Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Albert Einstein College of Medicine

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC-07-07-197-a26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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