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Advanced Cardiovascular Imaging Consortium (ACIC)

This study has been completed.
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Kavitha Chinnaiyan, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00640068
First received: March 14, 2008
Last updated: April 2, 2014
Last verified: April 2014

March 14, 2008
April 2, 2014
July 2007
April 2014   (final data collection date for primary outcome measure)
Educate participating sites on appropriate use of CCTA [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To educate participating sites in the clinical uses of CCTA recommended by the ACC/ACR as well as other best-practices
To educate participating sites in the clinical uses recommended by the ACC/ACR. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00640068 on ClinicalTrials.gov Archive Site
To monitor the CQI process of individual participating sites and the ACIC as a whole. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To monitor the CQI process of individual participating sites and the ACIC as a whole. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Advanced Cardiovascular Imaging Consortium
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.

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.

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

Referral from other healthcare provider or support staff (e.g. physician office, clinics), Emergency Room, self referral with prescription

  • Chest Pain
  • Coronary Occlusion
  • Coronary Artery Disease
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42926
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00640068
2007-236
No
Kavitha Chinnaiyan, William Beaumont Hospitals
William Beaumont Hospitals
Blue Cross Blue Shield of Michigan Foundation
Study Director: Kavitha Chinnaiyan, MD William Beaumont Hospitals
William Beaumont Hospitals
April 2014

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