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

Physicians International CCTA Utilization Registry

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94111
      • MDDX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults (18 or older) who are scheduled to undergo a CCTA imaging procedure.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CCTA utilization parameters and clinical findings	Two years

Secondary Outcome Measures

Outcome Measure	Time Frame
90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies	Two years

Collaborators and Investigators

• Sponsor: MDDX LLC
• Investigators: Study Director: Dan Gebow, PhD, MDDX LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 5, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 8, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Myocardial Infarction
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: bigPICTURE