Chest PainACICNCT00640068
Advanced Cardiovascular Imaging Consortium
An observational study of Chest Pain and Coronary Occlusion, run by Corewell Health East at 50 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Coronary Occlusion, Coronary Artery Disease
- How many people
- 42,926 participants
- Where
- 50 sitesUnited States
- Study dates
- Jul 2007to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Referral from other healthcare provider or support staff (e.g. physician office, clinics), Emergency Room, self referral with prescription
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
University of Michigan
Ann Arbor, Michigan, 48109
St. Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48706
Bay Regional Medical Center
Bay City, Michigan, 48708
DMC Huron Valley-Sinai
Commerce, Michigan, 48382
Oakwood Hospital
Dearborn, Michigan, 48124
Harper University Hospital
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
St. John Hospital and Medical Center
Detroit, Michigan, 48236
McLaren Flint
Flint, Michigan, 48532
McLaren Regional Medical Center
Flint, Michigan, 48532
Premier Medical Clinics
Flint, Michigan, 48532
Garden City Hospital
Garden City, Michigan, 48135
North Ottawa Community Hospital
Grand Haven, Michigan, 49417
East Beltline Imaging
Grand Rapids, Michigan, 49525
Henry Ford Cottage Hospital
Grosse Pointe, Michigan, 48043
William Beaumont Hospital - Grosse Pointe
Grosse Pointe, Michigan, 48230
Hillsdale Community Health Center
Hillsdale, Michigan, 49242
Bronson Hospital
Kalamazoo, Michigan, 49007
Borgess Medical Center
Kalamazoo, Michigan, 49048
Sparrow Health System
Lansing, Michigan, 48909
Ingham Regional Medical Center
Lansing, Michigan, 48910
Thoracic and Cardiovascular Institute, P.C.
Lansing, Michigan, 48910
McLaren Lapeer Region
Lapeer, Michigan, 48446
St. John Oakland
Madison Heights, Michigan, 48071
Marquette General Health System
Marquette, Michigan, 49855
Mercy Memorial
Monroe, Michigan, 48162
McLaren Macomb
Mount Clemens, Michigan, 48043
Hackley Hospital
Muskegon, Michigan, 49442
Northern Michigan Hospital
Petoskey, Michigan, 49770
Pontiac Osteopathic Hospital
Pontiac, Michigan, 48124
St. Joseph Mercy Hospital Oakland
Pontiac, Michigan, 48341
Crittenton Hospital
Rochester, Michigan, 48307
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
Covenant Healthcare
Saginaw, Michigan, 48602
Lakeland Regional Health System
Saint Joseph, Michigan, 49085
Chippewa County War Memorial
Sault Saint Marie, Michigan, 49783
St. John Providence Hospital
Southfield, Michigan, 48075
Southgate Radiology & Southgate CT
Southgate, Michigan, 48195
St. Joseph Health System - Tawas
Tawas City, Michigan, 48764
Heritage (Oakwood) Hospital
Taylor, Michigan, 48180
Munson Medical Center
Traverse City, Michigan, 49684
Oakwood Southshore Medical Center
Trenton, Michigan, 48183
William Beaumont Hospital, Troy
Troy, Michigan, 48085-1117
St. John Macomb
Warren, Michigan, 48093
Oakwood Annapolis Hospital
Wayne, Michigan, 48184
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Health First Imaging
West Bloomfield, Michigan, 48323
West Branch Regional Medical Center
West Branch, Michigan, 48661
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192
Michigan Heart, P.C.
Ypsilanti, Michigan, 48197
About this study
Official title: Advanced Cardiovascular Imaging Consortium: A Collaborative Quality Improvement Project
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.
Read the 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.
- Conditions
- Chest Pain, Coronary Occlusion, Coronary Artery Disease
- Keywords
- coronary artery disease, chest pain, coronary artery bypass graft, stress test, Coronary Angiography
- Medical subject headings
- Chest Pain, Coronary Occlusion, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Educate participating sites on appropriate use of CCTA
To educate participating sites in the clinical uses of CCTA recommended by the ACC/ACR as well as other best-practices
Measured: 5 years
Secondary outcomes (1)
To monitor the CQI process of individual participating sites and the ACIC as a whole.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42,926 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Kavitha Chinnaiyan, Corewell Health East
- Investigators
- Kavitha Chinnaiyan, MD, Study director, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640068
- Sponsor's protocol ID
- 2007-236
- Acronym
- ACIC
- Status last verified
- Apr 2014
- First submitted
- 14 Mar 2008
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26093928Chinnaiyan 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.
PubMed 23926193Chinnaiyan 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.
PubMed 22424004Chinnaiyan 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.
PubMed 22322086Vanhecke 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.
PubMed 21775504Raff 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.
PubMed 19509381
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Cardiovascular Imaging Consortium: A Collaborative Quality Improvement Project
- ClinicalTrials.gov ID
- NCT00640068
- Acronym / sponsor ID
- ACIC / 2007-236
- Conditions
- Chest Pain, Coronary Occlusion, Coronary Artery Disease
- Keywords
- coronary artery disease, chest pain, coronary artery bypass graft, stress test, Coronary Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,926 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Jul 2007
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Referral from other healthcare provider or support staff (e.g. physician office, clinics), Emergency Room, self referral with prescription
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Educate participating sites on appropriate use of CCTA
Time frame: 5 years
To educate participating sites in the clinical uses of CCTA recommended by the ACC/ACR as well as other best-practices
1 secondary outcome
To monitor the CQI process of individual participating sites and the ACIC as a whole.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
- Derived from this study: PubMed 26093928Burris 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.
- Derived from this study: PubMed 23926193Chinnaiyan 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.
- Derived from this study: PubMed 22424004Chinnaiyan 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.
- Derived from this study: PubMed 22322086Chinnaiyan 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.
- Derived from this study: PubMed 21775504Vanhecke 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.
- Derived from this study: PubMed 19509381Raff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavitha Chinnaiyan, MD study director
Corewell Health East
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Coronary Occlusion, run by Corewell Health East at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Educate participating sites on appropriate use of CCTA (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640068, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.