Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-01 @ 4:17 PM
Study NCT ID:
NCT00640068
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2008-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Cardiovascular Imaging Consortium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D054059', 'term': 'Coronary Occlusion'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42926}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2008-03-14', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Educate participating sites on appropriate use of CCTA', 'timeFrame': '5 years', 'description': 'To educate participating sites in the clinical uses of CCTA recommended by the ACC/ACR as well as other best-practices'}], 'secondaryOutcomes': [{'measure': 'To monitor the CQI process of individual participating sites and the ACIC as a whole.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'chest pain', 'coronary artery bypass graft', 'stress test', 'Coronary Angiography'], 'conditions': ['Chest Pain', 'Coronary Occlusion', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '26093928', 'type': 'DERIVED', '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.'}, {'pmid': '23926193', 'type': 'DERIVED', '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.'}, {'pmid': '22424004', 'type': 'DERIVED', '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.'}, {'pmid': '22322086', 'type': 'DERIVED', '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.'}, {'pmid': '21775504', 'type': 'DERIVED', '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.'}, {'pmid': '19509381', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Referral from other healthcare provider or support staff (e.g. physician office, clinics), Emergency Room, self referral with prescription', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n(Patient must meet one criteria)\n\n* Patient has had a CCTA examination ordered by a referring physician at a participating site.\n* Patient is a self referral.\n\nExclusion Criteria:\n\nClinical contraindications to CCTA are present as determined by attending physician or staff, including but not limited to:\n\n* Pregnancy or potential pregnancy.\n* Renal failure or dysfunction.\n* Inability to receive beta blockers.\n* Allergy to iodinated contrast without prior premedication.\n* Unwillingness to participate.\n* Inability to read or understand Patient Information Sheet.\n* 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."}, 'identificationModule': {'nctId': 'NCT00640068', 'acronym': 'ACIC', 'briefTitle': 'Advanced Cardiovascular Imaging Consortium', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Advanced Cardiovascular Imaging Consortium: A Collaborative Quality Improvement Project', 'orgStudyIdInfo': {'id': '2007-236'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48706', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy Hospital Ann Arbor', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48708', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bay Regional Medical Center', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48382', 'city': 'Commerce', 'state': 'Michigan', 'country': 'United States', 'facility': 'DMC Huron Valley-Sinai', 'geoPoint': {'lat': 42.59114, 'lon': -83.49077}}, {'zip': '48124', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakwood Hospital', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper University Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Hospital and Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48532', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Flint', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48532', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Regional Medical Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48532', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Premier Medical Clinics', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48135', 'city': 'Garden City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Garden City Hospital', 'geoPoint': {'lat': 42.32559, 'lon': -83.33104}}, {'zip': '49417', 'city': 'Grand Haven', 'state': 'Michigan', 'country': 'United States', 'facility': 'North Ottawa Community Hospital', 'geoPoint': {'lat': 43.06307, 'lon': -86.22839}}, {'zip': '49525', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'East Beltline Imaging', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48043', 'city': 'Grosse Pointe', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Cottage Hospital', 'geoPoint': {'lat': 42.38615, 'lon': -82.91186}}, {'zip': '48230', 'city': 'Grosse Pointe', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital - Grosse Pointe', 'geoPoint': {'lat': 42.38615, 'lon': -82.91186}}, {'zip': '49242', 'city': 'Hillsdale', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hillsdale Community Health Center', 'geoPoint': {'lat': 41.92005, 'lon': -84.63051}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Hospital', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Borgess Medical Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48909', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sparrow Health System', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ingham Regional Medical Center', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Thoracic and Cardiovascular Institute, P.C.', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48446', 'city': 'Lapeer', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Lapeer Region', 'geoPoint': {'lat': 43.05142, 'lon': -83.31883}}, {'zip': '48071', 'city': 'Madison Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Oakland', 'geoPoint': {'lat': 42.48587, 'lon': -83.1052}}, {'zip': '49855', 'city': 'Marquette', 'state': 'Michigan', 'country': 'United States', 'facility': 'Marquette General Health System', 'geoPoint': {'lat': 46.54354, 'lon': -87.39542}}, {'zip': '48162', 'city': 'Monroe', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mercy Memorial', 'geoPoint': {'lat': 41.91643, 'lon': -83.39771}}, {'zip': '48043', 'city': 'Mount Clemens', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Macomb', 'geoPoint': {'lat': 42.59726, 'lon': -82.87798}}, {'zip': '49442', 'city': 'Muskegon', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hackley Hospital', 'geoPoint': {'lat': 43.23418, 'lon': -86.24839}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'facility': 'Northern Michigan Hospital', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}, {'zip': '48124', 'city': 'Pontiac', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pontiac Osteopathic Hospital', 'geoPoint': {'lat': 42.63892, 'lon': -83.29105}}, {'zip': '48341', 'city': 'Pontiac', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy Hospital Oakland', 'geoPoint': {'lat': 42.63892, 'lon': -83.29105}}, {'zip': '48307', 'city': 'Rochester', 'state': 'Michigan', 'country': 'United States', 'facility': 'Crittenton Hospital', 'geoPoint': {'lat': 42.68059, 'lon': -83.13382}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital-Royal Oak', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Covenant Healthcare', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lakeland Regional Health System', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '49783', 'city': 'Sault Saint Marie', 'state': 'Michigan', 'country': 'United States', 'facility': 'Chippewa County War Memorial'}, {'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Providence Hospital', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '48195', 'city': 'Southgate', 'state': 'Michigan', 'country': 'United States', 'facility': 'Southgate Radiology & Southgate CT', 'geoPoint': {'lat': 42.21393, 'lon': -83.19381}}, {'zip': '48764', 'city': 'Tawas City', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Health System - Tawas', 'geoPoint': {'lat': 44.26946, 'lon': -83.5147}}, {'zip': '48180', 'city': 'Taylor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Heritage (Oakwood) Hospital', 'geoPoint': {'lat': 42.24087, 'lon': -83.26965}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Munson Medical Center', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '48183', 'city': 'Trenton', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakwood Southshore Medical Center', 'geoPoint': {'lat': 42.13949, 'lon': -83.17826}}, {'zip': '48085-1117', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital, Troy', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '48093', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Macomb', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '48184', 'city': 'Wayne', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakwood Annapolis Hospital', 'geoPoint': {'lat': 42.28143, 'lon': -83.38632}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford West Bloomfield Hospital', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '48323', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Health First Imaging', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '48661', 'city': 'West Branch', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Branch Regional Medical Center', 'geoPoint': {'lat': 44.27641, 'lon': -84.23861}}, {'zip': '48192', 'city': 'Wyandotte', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Wyandotte Hospital', 'geoPoint': {'lat': 42.21421, 'lon': -83.14992}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Heart, P.C.', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}], 'overallOfficials': [{'name': 'Kavitha Chinnaiyan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corewell Health East'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield of Michigan Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director of Noninvasive Cardiology Education; Program Director, ACIC', 'investigatorFullName': 'Kavitha Chinnaiyan', 'investigatorAffiliation': 'Corewell Health East'}}}}