Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry

NCT00932958 | Completed DMC

• 1 other identifier: bigPICTURE
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• CCTA utilization parameters and clinical findings

  Two years

Secondary Outcomes (1)

• 90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies

  Two years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MDDX LLC: lead

Study Sites (1)

MDDX

San Francisco, California, 94111, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Dan Gebow, PhD

  MDDX LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2009
• First Posted: July 7, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

US (1)