Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry (BIGPICTURE)
This protocol describes an observational study whose goal is to collect de-identified Coronary CT Angiography (CCTA) acquisition factors and interpretations (findings) from several hundred U.S. and international imaging facilities. The study uses an electronic data capture tool to collect de-identified CCTA utilization parameters and clinical findings in order to create a multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings. The registry will be used to determine areas of interest for future randomized controlled trials.
All data will be collected with patient identifiers removed and in complete accordance with HIPAA regulations. All data will be analyzed in aggregate, thus further minimizing the risk of patient confidentiality violations.
Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Physicians International CCTA Utilization Registry|
- CCTA utilization parameters and clinical findings [ Time Frame: Two years ] [ Designated as safety issue: No ]
- 90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies [ Time Frame: Two years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
All comers >18 yrs old
This study is observational, studying patients who are already scheduled to undergo CCTA. Minors and those unable to consent to the study are excluded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932958
|United States, California|
|San Francisco, California, United States, 94111|
|Study Director:||Dan Gebow, PhD||MDDX LLC|