Study Stopped
Accrual
Perfusion Imaging and CT -Understanding Relative Efficacy
PICTURE
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.
1 other identifier
interventional
249
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 12, 2007
CompletedFirst Posted
Study publicly available on registry
June 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
August 23, 2017
CompletedAugust 23, 2017
July 1, 2017
10 months
June 12, 2007
May 3, 2017
July 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.
Number of subjects with CT for detection purposes
through study completion, an expected average of 1 year
Secondary Outcomes (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).
1 year outcomes after initial MPS exam
Study Arms (1)
Imaging
EXPERIMENTALGeneral imaging subjects receiving CT exams
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
Study Sites (1)
GE Healthcare
Waukesha, Wisconsin, 53188, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela N. Johnson, Senior Manager Clinical Affairs Operations
- Organization
- GE Healthcare
Study Officials
- STUDY CHAIR
Matthew Budoff
LA Biomedical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2007
First Posted
June 14, 2007
Study Start
June 1, 2007
Primary Completion
April 1, 2008
Study Completion
December 1, 2009
Last Updated
August 23, 2017
Results First Posted
August 23, 2017
Record last verified: 2017-07