Perfusion Imaging and CT -Understanding Relative Efficacy (PICTURE)

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00486447
First received: June 12, 2007
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.


Condition Intervention
Coronary Artery Disease
Device: 64 Channel VCT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective Multi-center Study Comparing Cardiac Computed Tomography (CT) Using a 64-detector Row Volumetric Computed Tomography (VCT) Scanner for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging.

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Sensitivity, Specificity, NPV of CCTA and MPS for detecting significant coronary artery disease using diagnostic catheterization for standard of truth. [ Time Frame: Statistical performance analysis to be done upon completion of blinded reads. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcomes - EKG, laboratory workup, changes in medical management, downstream cardiac testing, significant coronary interventions, and major cardiac events & long-term outcomes (non-fatal MI and cardiac-related death). [ Time Frame: 1 year outcomes after initial MPS exam ] [ Designated as safety issue: No ]

Enrollment: 249
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 64 Channel VCT
    cardiac CT angiography exam
Detailed Description:

This study is a prospective, multi-center, within-subject comparative study. One hundred fifty (150) subjects with CATH procedures are needed in the study. Approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for MPS for a definitive diagnosis of CAD.

Each subject will undergo the following procedures:

  • A Myocardial Perfusion Study (MPS) procedure, as standard of care;
  • An IV contrast-enhanced cardiac CT (CCTA) procedure;
  • A CATH procedure when the MPS and/or cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure.

When both the MPS and CCTA are normal, the subject is not required to undergo a CATH procedure, but will enter into follow-up. The research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac CT procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with an intermediate probability risk for coronary artery disease.
  • Subject has symptoms of suspected ischemic heart disease.
  • Subject is at intermediate risk for coronary artery disease

Exclusion Criteria:

  • The subject has undergone a prior CCTA within 6 months prior to entering the study.
  • The subject has a documented history of CAD by CATH, myocardial infarction (MI), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (CABG) procedure
  • The subject has hemodynamic or active clinical instability:

    • Acute chest pain (sudden onset);
    • Cardiac shock;
    • Unstable blood pressure (BP);
    • Severe congestive heart failure or acute pulmonary edema.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486447

Locations
United States, Wisconsin
GE Healthcare
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
GE Healthcare
Investigators
Study Chair: Matthew Budoff LA Biomedical Research Institute
  More Information

No publications provided

Responsible Party: Robert Honigberg/Chief Medical Officer, GE Healthcare
ClinicalTrials.gov Identifier: NCT00486447     History of Changes
Other Study ID Numbers: GE-189-03
Study First Received: June 12, 2007
Last Updated: March 25, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014