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Perfusion Imaging and CT -Understanding Relative Efficacy (PICTURE)

This study has been terminated.
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: June 12, 2007
Last updated: July 24, 2017
Last verified: July 2017
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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth. [ Time Frame: through study completion, an expected average of 1 year ]
    Number of subjects with CT for detection purposes

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 ]

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)
Arms Assigned Interventions
Experimental: Imaging
General imaging subjects receiving CT exams
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00486447

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

Responsible Party: GE Healthcare Identifier: NCT00486447     History of Changes
Other Study ID Numbers: GE-189-03
Study First Received: June 12, 2007
Results First Received: May 3, 2017
Last Updated: July 24, 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on September 21, 2017