Full Text View
Tabular View
No Study Results Posted
Related Studies
Advanced Cardiovascular Imaging Consortium (ACIC)
This study is currently recruiting participants.
Verified by William Beaumont Hospitals, March 2009
First Received: March 14, 2008   Last Updated: March 2, 2009   History of Changes
Sponsored by: 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: Cohort, 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:
  • 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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

Locations
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Ann DePetris, RN,MSA     248-551-6683     Ann.Depetris@beaumont.edu    
Principal Investigator: Gilbert Raff, MD            
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49048
Contact: Susan K Smith, MSN     269-226-8261     susanksmith@borgess.com    
Principal Investigator: Mark Shaman, MD            
Bronson Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Joshua Burnett, CT     269-341-6380     burnettj@bronsonhg.org    
Principal Investigator: Robert Williams, DO            
Chippewa County War Memorial Recruiting
Sault Saint Marie, Michigan, United States, 49783
Contact: Erin Stocker     906-635-4617     esnyder@wmhos.org    
Principal Investigator: Ralph Duman, MD            
Crittenton Hospital Recruiting
Rochester, Michigan, United States, 48307
Contact: Sharon James, RN     248-652-5286     sjames@crittenton.com    
Principal Investigator: Katharine Scharer, MD,FACR            
Hackley Hospital Recruiting
Muskegon, Michigan, United States, 49442
Contact: David Aslakson, RN     231-723-4740     daslakso@hackley-health.org    
Principal Investigator: Ralph Ryan, MD            
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Michael Davis     313-916-7925     Michaeld@rad.hfh.edu    
Principal Investigator: Thomas Song, MD            
Heritage (Oakwood) Hospital Recruiting
Taylor, Michigan, United States, 48180
Contact: Diane Tesner     313-375-7050     tesnerd@oakwood.org    
Principal Investigator: John Finger, MD            
Hillsdale Community Health Center Recruiting
Hillsdale, Michigan, United States, 49242
Contact: Cindy Barker     517-437-5153     cbarker@hchc.com    
Principal Investigator: Joseph Painter, MD            
Lakeland Regional Health System Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Angie Padilla     269-983-8257     apadilla@lakelandregional.org    
Principal Investigator: Nathan Jordan, MD            
Marquette General Health System Recruiting
Marquette, Michigan, United States, 49855
Contact: Deb Graves     906-225-4947     dgraves@mgh.org    
Principal Investigator: Steve Min, MD            
Mercy Memorial Recruiting
Monroe, Michigan, United States, 48162
Contact: Valerie Mefferd     734-240-5637     Valerie.Mefferd@MercyMemorial.org    
Principal Investigator: Norma A Flores, MD            
Michigan Heart, P.C. Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Thom Collard     734-712-2494     tcollard@michiganheart.com    
Principal Investigator: Tauqir Goraya, MD,PhD            
Oakwood Hospital Recruiting
Dearborn, Michigan, United States, 48124
Contact: Joanne Gies, RN     313-438-7701     GiesJ@oakwood.org    
Principal Investigator: John Finger, MD            
Pontiac Osteopathic Hospital Recruiting
Pontiac, Michigan, United States, 48124
Contact: Shawn Cramton, RT     248-338-5699     shawn.cramton@pohmedical.org    
Principal Investigator: Quen Dickey, DO            
Sparrow Health System Recruiting
Lansing, Michigan, United States, 48909
Contact: Malinda Clark, RN     517-364-2503     malinda.clark@sparrow.org    
Principal Investigator: Ranji Samaraweera, MD            
St. John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Julie A Holland-Alter, RN     313-343-7870     julie.holland-alter@stjohn.org    
Principal Investigator: Anthony J Kawa, DO            
St. John Macomb Recruiting
Warren, Michigan, United States, 48093
Contact: Kathy Budka     586-573-5891     kathy.budka@stjohn.org    
Principal Investigator: Charles Nino, MD            
St. John Oakland Recruiting
Madison Heights, Michigan, United States, 48071
Contact: Kathy Budka     586-573-5891     kathy.budka@stjohn.org    
Principal Investigator: Joan Crawford, MD            
Southgate Radiology & Southgate CT Not yet recruiting
Southgate, Michigan, United States, 48195
Contact: Dennis Vollman, DO     734-281-7481     RTV0828@aol.com    
St. Joseph Mercy Hospital Ann Arbor Recruiting
Ann Arbor, Michigan, United States, 48706
Contact: Sheryl L Wildoner, BBA     734-712-3438     wildones@trinity-health.org    
Principal Investigator: Michael Sarosi, MD            
St. Joseph Mercy Hospital Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Jody Evans     248-858-3766     evansjol@trinity-health.org    
Principal Investigator: Sharath Chandra, MD            
Thoracic and Cardiovascular Institute, P.C. Recruiting
Lansing, Michigan, United States, 48910
Contact: Kyle Willing     517-483-8432     kwilling@tciheart.com    
Principal Investigator: Ronald Voice, MD            
William Beaumont Hospital, Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Kathy McCreedy-Hall, RN     248-898-9270     mailto:kathy.Mccreedy@beaumonthospitals.com    
Principal Investigator: Gilbert Raff, MD            
William Beaumont Hospital, Troy Recruiting
Troy, Michigan, United States, 48085-1117
Contact: Diana Bacon, RN     248-964-8500     dbacon@beaumonthospitals.com    
Principal Investigator: David Forst, MD            
West Michigan Cardiology Not yet recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Paul H Singh, MD, FACC     616-301-7500     singhh@wmcardiology.com    
Bay Regional Medical Center Not yet recruiting
Bay City, Michigan, United States, 48708
Contact: James Finch, MD     989-894-3080     james.finch@bhsnet.org    
DMC Huron Valley-Sinai Not yet recruiting
Commerce, Michigan, United States, 48382
Contact: John Kelly, DO     248-937-5020     jkelly@dmc.org    
Garden City Hospital Not yet recruiting
Garden City, Michigan, United States, 48135
Contact: Edsa Negussie, MD     734-458-3479     edsanegussie@yahoo.com    
Harper University Hospital Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Hamid Sattar, MD     313-993-7777     hsattar@dmc.org    
Ingham Regional Medical Center Not yet recruiting
Lansing, Michigan, United States, 48910
Contact: Ronald Voice, MD     517-483-7550     rvoice@tciheart.com    
Munson Medical Center Not yet recruiting
Traverse City, Michigan, United States, 49684
Contact: C. Paul Williams, MD     231-935-6008     cwilliams@mhc.net    
Northern Michigan Hospital Not yet recruiting
Petoskey, Michigan, United States, 49770
Contact: Gerald Gadowski, DO     231-487-2490     ggadowski@michiganhvs.com    
Oakwood Annapolis Hospital Not yet recruiting
Wayne, Michigan, United States, 48184
Contact: Venkat Rudraraju, MD     434-467-4174     rudrarajumd@gmail.com    
Oakwood Southshore Medical Center Not yet recruiting
Trenton, Michigan, United States, 48183
Contact: Bruno Borin, DO     734-671-3425     borinb@oakwood.org    
St. Joseph Health System - Tawas Not yet recruiting
Tawas City, Michigan, United States, 48764
Contact: Vikram Rao, MD     989-362-0710     vikrao@comcast.net    
St. Mary Mercy Hospital Not yet recruiting
Livonia, Michigan, United States, 48154
Contact: Christopher Esshaki     734-655-2823     esshakic@trinity-health.org    
William Beaumont Hospital - Grosse Pointe Not yet recruiting
Grosse Pointe, Michigan, United States, 48230
Contact: Georges Ghafari, MD     586-498-0401     georges.ghafari@beaumont.edu    
St. John Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact: Mike Harmer, RN     248-849-4590     Michael.Harmer@stjohn.org    
Principal Investigator: Souheil Saba, MD            
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Gilbert Raff, MD William Beaumont Hospitals
  More Information

No publications provided by William Beaumont Hospitals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: William Beaumont Hospital-Royal Oak, MI ( Gilbert Raff, MD )
Study ID Numbers: 2007-236
Study First Received: March 14, 2008
Last Updated: March 2, 2009
ClinicalTrials.gov Identifier: NCT00640068     History of Changes
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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Stress
Pain
Ischemia
Arteriosclerosis
Chest Pain
Coronary Disease
Coronary Occlusion
Signs and Symptoms
Coronary Artery Disease

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

ClinicalTrials.gov processed this record on September 10, 2009