Advanced Cardiovascular Imaging Consortium - Full Text View

Sponsor:	William Beaumont Hospitals
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00640068

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:

MedlinePlus related topics: Chest Pain Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

To educate participating sites in the clinical uses recommended by the ACC/ACR. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To monitor the CQI process of individual participating sites and the ACIC as a whole. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	12000
Study Start Date:	July 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (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

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

Contacts

Contact: Ann DePetris, RN,MSA

248.551.6683

Ann.DePetris@beaumont.edu

Show 50 Study Locations

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Study Director:	Kavitha Chinnaiyan, MD	William Beaumont Hospitals
Study Chair:	Gilbert Raff, 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):

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.

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.

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. Epub 2011 Jul 20.

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.

Responsible Party:	Kavitha Chinnaiyan, MD, William Beaumont Hospital-Royal Oak, MI
ClinicalTrials.gov Identifier:	NCT00640068 History of Changes
Other Study ID Numbers:	2007-236
Study First Received:	March 14, 2008
Last Updated:	April 3, 2011
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:

Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Occlusion
Pain

Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 24, 2012