Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry

NCT ID: NCT00932958

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MDDX LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Gebow, PhD

Role: STUDY_DIRECTOR

MDDX LLC

Locations

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MDDX

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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bigPICTURE

Identifier Type: -

Identifier Source: org_study_id