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
  Purpose

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.


Condition
Chest Pain
Coronary Occlusion
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advanced Cardiovascular Imaging Consortium: A Collaborative Quality Improvement Project

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • To monitor the CQI process of individual participating sites and the ACIC as a whole. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 42926
Study Start Date: July 2007
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640068

  Hide Study Locations
Locations
United States, Michigan
St. Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States, 48706
University of Michigan
Ann Arbor, Michigan, United States, 48109
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
DMC Huron Valley-Sinai
Commerce, Michigan, United States, 48382
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Harper University Hospital
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Premier Medical Clinics
Flint, Michigan, United States, 48532
McLaren Flint
Flint, Michigan, United States, 48532
McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Garden City Hospital
Garden City, Michigan, United States, 48135
North Ottawa Community Hospital
Grand Haven, Michigan, United States, 49417
East Beltline Imaging
Grand Rapids, Michigan, United States, 49525
William Beaumont Hospital - Grosse Pointe
Grosse Pointe, Michigan, United States, 48230
Henry Ford Cottage Hospital
Grosse Pointe, Michigan, United States, 48043
Hillsdale Community Health Center
Hillsdale, Michigan, United States, 49242
Bronson Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
Sparrow Health System
Lansing, Michigan, United States, 48909
Thoracic and Cardiovascular Institute, P.C.
Lansing, Michigan, United States, 48910
Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
McLaren Lapeer Region
Lapeer, Michigan, United States, 48446
St. John Oakland
Madison Heights, Michigan, United States, 48071
Marquette General Health System
Marquette, Michigan, United States, 49855
Mercy Memorial
Monroe, Michigan, United States, 48162
McLaren Macomb
Mount Clemens, Michigan, United States, 48043
Hackley Hospital
Muskegon, Michigan, United States, 49442
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
St. Joseph Mercy Hospital Oakland
Pontiac, Michigan, United States, 48341
Pontiac Osteopathic Hospital
Pontiac, Michigan, United States, 48124
Crittenton Hospital
Rochester, Michigan, United States, 48307
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Covenant Healthcare
Saginaw, Michigan, United States, 48602
Chippewa County War Memorial
Sault Saint Marie, Michigan, United States, 49783
St. John Providence Hospital
Southfield, Michigan, United States, 48075
Southgate Radiology & Southgate CT
Southgate, Michigan, United States, 48195
Lakeland Regional Health System
St. Joseph, Michigan, United States, 49085
St. Joseph Health System - Tawas
Tawas City, Michigan, United States, 48764
Heritage (Oakwood) Hospital
Taylor, Michigan, United States, 48180
Munson Medical Center
Traverse City, Michigan, United States, 49684
Oakwood Southshore Medical Center
Trenton, Michigan, United States, 48183
William Beaumont Hospital, Troy
Troy, Michigan, United States, 48085-1117
St. John Macomb
Warren, Michigan, United States, 48093
Oakwood Annapolis Hospital
Wayne, Michigan, United States, 48184
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
Health First Imaging
West Bloomfield, Michigan, United States, 48323
West Branch Regional Medical Center
West Branch, Michigan, United States, 48661
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, United States, 48192
Michigan Heart, P.C.
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
William Beaumont Hospitals
Blue Cross Blue Shield of Michigan Foundation
Investigators
Study Director: Kavitha Chinnaiyan, MD William Beaumont Hospitals
  More Information

No publications provided by William Beaumont Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kavitha Chinnaiyan, Medical Director of Noninvasive Cardiology Education; Program Director, ACIC, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00640068     History of Changes
Other Study ID Numbers: 2007-236
Study First Received: March 14, 2008
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
coronary artery disease
chest pain
coronary artery bypass graft
stress test
Coronary Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Chest Pain
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014