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:
Collaborator:
Albert Einstein College of Medicine of Yeshiva University
Information provided by (Responsible Party):
Jeffrey Levsky, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01106612
First received: April 12, 2010
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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of hospital stay (time to discharge) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of participants that have a subsequent non-fatal myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of participants that die due to any cause [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: April 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (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

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

No publications provided

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
Study First Received: April 12, 2010
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Angina Pectoris
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 16, 2014