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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

July 5, 2009
December 8, 2012
May 2009
December 2011   (final data collection date for primary outcome measure)
CCTA utilization parameters and clinical findings [ Time Frame: Two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00932958 on ClinicalTrials.gov Archive Site
90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies [ Time Frame: Two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Coronary Artery Disease
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6000
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932958
bigPICTURE
Yes
MDDX LLC
MDDX LLC
Not Provided
Study Director: Dan Gebow, PhD MDDX LLC
MDDX LLC
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP