Coronary Artery Disease
Conditions
Keywords
Myocardial Infarction
Brief summary
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.
Interventions
None listed
Sponsors
MDDX LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CCTA utilization parameters and clinical findings | Two years |
Secondary
| Measure | Time frame |
|---|---|
| 90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies | Two years |
Countries
United States
Outcome results
None listed