Clinical trial NCT00640068: Advanced Cardiovascular Imaging Consortium
Official title: Advanced Cardiovascular Imaging Consortium: A Collaborative Quality Improvement Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Coronary Occlusion
Coronary Artery Disease
Keywords: coronary artery disease
chest pain
coronary artery bypass graft
stress test
Coronary Angiography
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2008-03-20
Enrollment: 42926
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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 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.

Primary outcomes:
measure: Educate participating sites on appropriate use of CCTA
timeFrame: 5 years
Secondary outcomes:
measure: To monitor the CQI process of individual participating sites and the ACIC as a whole.
timeFrame: 5 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital Ann Arbor
state: Michigan
city: Bay City
country: United States
facility: Bay Regional Medical Center
state: Michigan
city: Commerce
country: United States
facility: DMC Huron Valley-Sinai
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Hospital
state: Michigan
city: Detroit
country: United States
facility: Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Flint
country: United States
facility: McLaren Flint
state: Michigan
city: Flint
country: United States
facility: McLaren Regional Medical Center
state: Michigan
city: Flint
country: United States
facility: Premier Medical Clinics
state: Michigan
city: Garden City
country: United States
facility: Garden City Hospital
state: Michigan
city: Grand Haven
country: United States
facility: North Ottawa Community Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: East Beltline Imaging
state: Michigan
city: Grosse Pointe
country: United States
facility: Henry Ford Cottage Hospital
state: Michigan
city: Grosse Pointe
country: United States
facility: William Beaumont Hospital - Grosse Pointe
state: Michigan
city: Hillsdale
country: United States
facility: Hillsdale Community Health Center
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Health System
state: Michigan
city: Lansing
country: United States
facility: Ingham Regional Medical Center
state: Michigan
city: Lansing
country: United States
facility: Thoracic and Cardiovascular Institute, P.C.
state: Michigan
city: Lapeer
country: United States
facility: McLaren Lapeer Region
state: Michigan
city: Madison Heights
country: United States
facility: St. John Oakland
state: Michigan
city: Marquette
country: United States
facility: Marquette General Health System
state: Michigan
city: Monroe
country: United States
facility: Mercy Memorial
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Muskegon
country: United States
facility: Hackley Hospital
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Pontiac
country: United States
facility: Pontiac Osteopathic Hospital
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Hospital Oakland
state: Michigan
city: Rochester
country: United States
facility: Crittenton Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Royal Oak
state: Michigan
city: Saginaw
country: United States
facility: Covenant Healthcare
state: Michigan
city: Sault Saint Marie
country: United States
facility: Chippewa County War Memorial
state: Michigan
city: Southfield
country: United States
facility: St. John Providence Hospital
state: Michigan
city: Southgate
country: United States
facility: Southgate Radiology & Southgate CT
state: Michigan
city: St. Joseph
country: United States
facility: Lakeland Regional Health System
state: Michigan
city: Tawas City
country: United States
facility: St. Joseph Health System - Tawas
state: Michigan
city: Taylor
country: United States
facility: Heritage (Oakwood) Hospital
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Trenton
country: United States
facility: Oakwood Southshore Medical Center
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital, Troy
state: Michigan
city: Warren
country: United States
facility: St. John Macomb
state: Michigan
city: Wayne
country: United States
facility: Oakwood Annapolis Hospital
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: West Bloomfield
country: United States
facility: Health First Imaging
state: Michigan
city: West Branch
country: United States
facility: West Branch Regional Medical Center
state: Michigan
city: Wyandotte
country: United States
facility: Henry Ford Wyandotte Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart, P.C.
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kavitha Chinnaiyan, MD
role: STUDY_DIRECTOR
References:
citation: Burris AC 2nd, Boura JA, Raff GL, Chinnaiyan KM. Triple Rule Out Versus Coronary CT Angiography in Patients With Acute Chest Pain: Results From the ACIC Consortium. JACC Cardiovasc Imaging. 2015 Jul;8(7):817-25. doi: 10.1016/j.jcmg.2015.02.023. Epub 2015 Jun 17.
citation: Chinnaiyan KM, Boura JA, DePetris A, Gentry R, Abidov A, Share DA, Raff GL; Advanced Cardiovascular Imaging Consortium Coinvestigators. Progressive radiation dose reduction from coronary computed tomography angiography in a statewide collaborative quality improvement program: results from the Advanced Cardiovascular Imaging Consortium. Circ Cardiovasc Imaging. 2013 Sep;6(5):646-54. doi: 10.1161/CIRCIMAGING.112.000237. Epub 2013 Aug 7.
citation: Chinnaiyan KM, Depetris AM, Al-Mallah M, Abidov A, Ananthasubramaniam K, Gallagher MJ, Girard S, Goraya TY, Kazerooni EA, Patel S, Peyser P, Poopat C, Raff GL, Saba S, Song T, Share D. Rationale, design, and goals of the Advanced Cardiovascular Imaging Consortium (ACIC): A Blue Cross Blue Shield of Michigan collaborative quality improvement project. Am Heart J. 2012 Mar;163(3):346-53. doi: 10.1016/j.ahj.2011.11.018.
citation: Chinnaiyan KM, Raff GL, Goraya T, Ananthasubramaniam K, Gallagher MJ, Abidov A, Boura JA, Share D, Peyser PA. Coronary computed tomography angiography after stress testing: results from a multicenter, statewide registry, ACIC (Advanced Cardiovascular Imaging Consortium). J Am Coll Cardiol. 2012 Feb 14;59(7):688-95. doi: 10.1016/j.jacc.2011.10.886.
citation: Vanhecke TE, Madder RD, Weber JE, Bielak LF, Peyser PA, Chinnaiyan KM. Development and validation of a predictive screening tool for uninterpretable coronary CT angiography results. Circ Cardiovasc Imaging. 2011 Sep;4(5):490-7. doi: 10.1161/CIRCIMAGING.111.964205. Epub 2011 Jul 20.
citation: Raff GL, Chinnaiyan KM, Share DA, Goraya TY, Kazerooni EA, Moscucci M, Gentry RE, Abidov A; Advanced Cardiovascular Imaging Consortium Co-Investigators. Radiation dose from cardiac computed tomography before and after implementation of radiation dose-reduction techniques. JAMA. 2009 Jun 10;301(22):2340-8. doi: 10.1001/jama.2009.814.