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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MDDX LLC
ClinicalTrials.gov Identifier:
NCT00932958
First received: July 5, 2009
Last updated: December 8, 2012
Last verified: December 2012
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physicians International CCTA Utilization Registry

Resource links provided by NLM:


Further study details as provided by MDDX LLC:

Primary Outcome Measures:
  • CCTA utilization parameters and clinical findings [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 6000
Study Start Date: May 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932958

Locations
United States, California
MDDX
San Francisco, California, United States, 94111
Sponsors and Collaborators
MDDX LLC
Investigators
Study Director: Dan Gebow, PhD MDDX LLC
  More Information

No publications provided

Responsible Party: MDDX LLC
ClinicalTrials.gov Identifier: NCT00932958     History of Changes
Other Study ID Numbers: bigPICTURE
Study First Received: July 5, 2009
Last Updated: December 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by MDDX LLC:
Myocardial Infarction

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014