Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry (BIGPICTURE)

MDDX

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00932958

bigPICTURE

Details and patient eligibility

About

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.

Enrollment: 6,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants who are able and willing to consent for themselves
• Patients scheduled for CCTA examination

Exclusion criteria

• Patients who did not complete the planned CT imaging procedure due to mechanical error of the CT machine.

Trial design

6,000 participants in 1 patient group

All comers >18 yrs old

Description:

This study is observational, studying patients who are already scheduled to undergo CCTA. Minors and those unable to consent to the study are excluded.