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NCT00640068 Clinical Trial

Advanced Cardiovascular Imaging Consortium

Coronary Artery Disease Clinical Trial

— ACIC  

Official title:
Advanced Cardiovascular Imaging Consortium: A Collaborative Quality Improvement Project

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00640068
Other study ID # 2007-236
Secondary ID
Status Completed
Phase N/A
First received March 14, 2008
Last updated April 2, 2014
Start date July 2007
Est. completion date April 2014

Study information
Verified date April 2014
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The ACIC is a Collaborative Quality Improvement (CQI) program involving the collection of data related to: indications for Coronary Computed Tomography (CCTA), patient health characteristics, acquisition techniques of CCTA scans, physician interpretation of results and short-term outcomes over a 90 day period.

Description:

This study is a collaborative quality assurance initiative organized by Blue Cross Blue Shield of Michigan and Blue Cross Network (BCBSM/BCN) for initiation of insurance coverage of coronary artery CT scanning (CCTA), a relatively new procedure that can provide non-invasive coronary angiograms. While this procedure has promise in that it can rapidly diagnose patients with unknown chest pain and reduce the cost of medical care, there is substantial potential for abuse and excess cost and inappropriate care if not appropriately used.

The Consortium's objectives are to educate participating sites of the clinical uses of CCTA as well as other best-practice recommendations; to create a database (Registry) to develop evidence of the best-practice utilization of CCTA; to provide a feedback mechanism to the sites about the positive or negative evidence of best-practice utilization of CCTA; to develop strategies to improve the utilization of CCTA; to monitor the CQI process of the individual participating sites; to reduce cost and improve safety and efficiency in in the care of patients with acute chest pain, indeterminate stress tests results, and to assess coronary bypass graft patency.

Recruitment information / eligibility
Status Completed
Enrollment 42926
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

(Patient must meet one criteria)

- Patient has had a CCTA examination ordered by a referring physician at a participating site.

- Patient is a self referral.

Exclusion Criteria:

Clinical contraindications to CCTA are present as determined by attending physician or staff, including but not limited to:

- Pregnancy or potential pregnancy.

- Renal failure or dysfunction.

- Inability to receive beta blockers.

- Allergy to iodinated contrast without prior premedication.

- Unwillingness to participate.

- Inability to read or understand Patient Information Sheet.

- Age less than 18 years without parent or guardian's evaluation of Patient Information Sheet. Underage and other vulnerable populations are included as the CQI process is intended to detect and correct adverse consequences of CCTA, e.g., excessive radiation, and protect such patients.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States St. Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Ann Arbor Michigan
United States Bay Regional Medical Center Bay City Michigan
United States DMC Huron Valley-Sinai Commerce Michigan
United States Oakwood Hospital Dearborn Michigan
United States Harper University Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States St. John Hospital and Medical Center Detroit Michigan
United States McLaren Flint Flint Michigan
United States McLaren Regional Medical Center Flint Michigan
United States Premier Medical Clinics Flint Michigan
United States Garden City Hospital Garden City Michigan
United States North Ottawa Community Hospital Grand Haven Michigan
United States East Beltline Imaging Grand Rapids Michigan
United States Henry Ford Cottage Hospital Grosse Pointe Michigan
United States William Beaumont Hospital - Grosse Pointe Grosse Pointe Michigan
United States Hillsdale Community Health Center Hillsdale Michigan
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Hospital Kalamazoo Michigan
United States Ingham Regional Medical Center Lansing Michigan
United States Sparrow Health System Lansing Michigan
United States Thoracic and Cardiovascular Institute, P.C. Lansing Michigan
United States McLaren Lapeer Region Lapeer Michigan
United States St. John Oakland Madison Heights Michigan
United States Marquette General Health System Marquette Michigan
United States Mercy Memorial Monroe Michigan
United States McLaren Macomb Mount Clemens Michigan
United States Hackley Hospital Muskegon Michigan
United States Northern Michigan Hospital Petoskey Michigan
United States Pontiac Osteopathic Hospital Pontiac Michigan
United States St. Joseph Mercy Hospital Oakland Pontiac Michigan
United States Crittenton Hospital Rochester Michigan
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Covenant Healthcare Saginaw Michigan
United States Chippewa County War Memorial Sault Saint Marie Michigan
United States St. John Providence Hospital Southfield Michigan
United States Southgate Radiology & Southgate CT Southgate Michigan
United States Lakeland Regional Health System St. Joseph Michigan
United States St. Joseph Health System - Tawas Tawas City Michigan
United States Heritage (Oakwood) Hospital Taylor Michigan
United States Munson Medical Center Traverse City Michigan
United States Oakwood Southshore Medical Center Trenton Michigan
United States William Beaumont Hospital, Troy Troy Michigan
United States St. John Macomb Warren Michigan
United States Oakwood Annapolis Hospital Wayne Michigan
United States Health First Imaging West Bloomfield Michigan
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States West Branch Regional Medical Center West Branch Michigan
United States Henry Ford Wyandotte Hospital Wyandotte Michigan
United States Michigan Heart, P.C. Ypsilanti Michigan

Sponsors (2)
Lead Sponsor Collaborator
William Beaumont Hospitals Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Educate participating sites on appropriate use of CCTA To educate participating sites in the clinical uses of CCTA recommended by the ACC/ACR as well as other best-practices 5 years No
Secondary To monitor the CQI process of individual participating sites and the ACIC as a whole. 5 years No
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