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Perfusion Imaging and CT -Understanding Relative Efficacy (PICTURE)

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ClinicalTrials.gov Identifier: NCT00486447
Recruitment Status : Terminated (Accrual)
First Posted : June 14, 2007
Results First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Coronary Artery Disease Device: 64 Channel VCT

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
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.
Study Start Date : June 2007
Primary Completion Date : April 2008
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Imaging
General imaging subjects receiving CT exams
Device: 64 Channel VCT
cardiac CT angiography exam


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00486447     History of Changes
Other Study ID Numbers: GE-189-03
First Posted: June 14, 2007    Key Record Dates
Results First Posted: August 23, 2017
Last Update Posted: August 23, 2017
Last Verified: July 2017

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