Perfusion Imaging and CT -Understanding Relative Efficacy (PICTURE)
|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.|
- 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 ]
- 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 ]
|Study Start Date:||June 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486447
|United States, Wisconsin|
|Waukesha, Wisconsin, United States, 53188|
|Study Chair:||Matthew Budoff||LA Biomedical Research Institute|