Official Title: “Advanced Cardiovascular Imaging Consortium: A Collaborative Quality Improvement Project”

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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: October 2010

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.

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • All patients in whom a clinical CCTA was ordered by their physician at a participating site. Patient must have a prescription for CCTA ordered by their physician.

Primary Measures

• To educate participating sites in the clinical uses recommended by the ACC/ACR.
  • Time Frame: 3 years
    Safety Issue?: No

Secondary Measures

• To monitor the CQI process of individual participating sites and the ACIC as a whole.
  • Time Frame: 3 years
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: William Beaumont Hospitals

Overall Clinical Trial Officials and Contacts

Gilbert Raff, MD Principal Investigator William Beaumont Hospitals  

Overall Contact: Ann DePetris, RN,MSA 248.551.6683 Ann.DePetris@beaumont.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640068

Study ID Number: 2007-236

ClinicalTrials.gov Identifier: NCT00640068

Health Authority: United States: Institutional Review Board