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
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: 64 Channel VCT|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
General imaging subjects receiving CT exams
Device: 64 Channel VCT
cardiac CT angiography exam
- 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
- 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 ]
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
|United States, Wisconsin|
|Waukesha, Wisconsin, United States, 53188|
|Study Chair:||Matthew Budoff||LA Biomedical Research Institute|