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

This study has been terminated.
(low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106612
First Posted: April 20, 2010
Last Update Posted: April 8, 2015
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.
Collaborator:
Albert Einstein College of Medicine, Inc.
Information provided by (Responsible Party):
Jeffrey Levsky, Montefiore Medical Center
  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 known 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 CT angiography Procedure: Myocardial perfusion imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial Comparing Coronary CT Angiography and Radionuclide Stress Myocardial Perfusion Imaging in Symptomatic Inpatients With Known Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Jeffrey Levsky, Montefiore Medical Center:

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

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

Enrollment: 7
Study Start Date: April 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Coronary CTA
  • Coronary CT
  • CTA of the coronary arteries
  • CT of the coronary arteries
  • CTA
  • CCTA
  • Cardiac CTA
  • Cardiac CT
  • 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:
  • MPI
  • MPS
  • 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01106612


Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Albert Einstein College of Medicine, Inc.
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

Responsible Party: Jeffrey Levsky, Associate Director of Research, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01106612     History of Changes
Other Study ID Numbers: MMC-07-07-197-a26
First Submitted: April 12, 2010
First Posted: April 20, 2010
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Jeffrey Levsky, Montefiore Medical Center:
randomized controlled trial
controlled clinical trial
comparative effectiveness research
chest pain
angina pectoris
non-invasive cardiac imaging
nuclear stress testing
coronary CT angiography
coronary catheterization
coronary revascularization

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