Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
NCT ID: NCT01353612
Last Updated: 2020-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1626 participants
OBSERVATIONAL
2010-01-31
2017-12-31
Brief Summary
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Additionally, patients will be contacted by phone on an annual basis for 5 years to collect cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be made using invasive and non invasive imaging tools in order to assess correlations between vascular beds, imaging technologies and main cardiovascular events.
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Detailed Description
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A subset of patients enrolled into the main CAIN3 study will undergo a CTA. At sites where both CTA and PET imaging modalities exist, patients will be asked to undergo both tests. The CTA and PET scans can be done separately on 2 imaging beds on different days or performed on the same imaging bed, resulting in a combined CTA and PET scan being done in one scheduled visit. All imaging will be done within 90 days after the follow up IVUS.
The choice of radiotracer used (NaF or FDG) for PET imaging will be dependent upon site and availability on the day of the scan. A total of 120 patients will be enrolled in this substudy with approximately 50-60 undergoing CTA and PET.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for clinically indicated coronary angiography and possible ad hoc percutaneous coronary intervention (PCI) will be evaluated before their scheduled procedure.
* Written informed consent (approved by the Institutional Review Board \[IRB\]/Independent Ethics Committee \[IEC\]) obtained prior to any study specific procedures.
* Patients considered to be stable at enrollment (at the discretion of the investigator) are eligible provided they meet all other entry criteria.
* Angiogram meeting qualifying criteria
Exclusion Criteria
* Previous coronary artery bypass graft (CABG) surgery or probable need for CABG in the next 24 months.
* Patients who have symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class III or IV) at baseline.
* Patients with clinically significant valvular heart disease likely to require surgical repair or replacement during the treatment period of the study
* Any clinically significant medical condition or presence of any laboratory abnormality that is considered by the investigator to be clinically important and could interfere with the conduct of the study.
* The presence of severe liver disease as defined by the presence of cirrhosis, chronic active hepatitis, or chronic jaundice with hyperbilirubinemia,
* Patients with eGFR \< 45 ml/min prior to baseline imaging procedures, or with nephrotic syndrome
* Patients with a life expectancy less than 2 years.
* History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to the screening.
* Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canadian Atherosclerosis Imaging Network
NETWORK
Responsible Party
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Principal Investigators
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Jean-Claude Tardif, MD
Role: STUDY_CHAIR
Montreal Heart Institute
Locations
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Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Foothills Medical Centre
Calgary, British Columbia, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Interventional Cardiology Research, St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
John Health Science Center
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth II - Health Sciences Centre
Halifax, Nova Scotia, Canada
Cambridge Cardiac Care
Cambridge, Ontario, Canada
McMaster Clinic Hamilton General Hospital
Hamilton, Ontario, Canada
St-Mary's Hospital
Kitchener, Ontario, Canada
KMH Cardiology & Diagnostics Centre
Kitchener, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
KMH Cardiology & Diagnostics Centre
Mississauga, Ontario, Canada
Southlake Regional Health Center
Newmarket, Ontario, Canada
Heart Care Research
Oshawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Scarborough Cardiology Research
Scarborough Village, Ontario, Canada
Sunnybrook Health Science Center
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
CSSS-Hopital de Gatineau, secteur Hull
Gatineau, Quebec, Canada
Viacar Recherche Clinique
Greenfield Park, Quebec, Canada
CSSS de Laval
Laval, Quebec, Canada
Hopital Pierre Boucher
Longueuil, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHUM Hopital-Hôtel-Dieu
Montreal, Quebec, Canada
CUSM Montreal General Hospital
Montreal, Quebec, Canada
Hopital Sacré-Cœur de Montreal
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada
Centre Hospitalier Régional de Lanaudière
Saint-Charles-Borromée, Quebec, Canada
Centre de santé et des services sociaux de Beauce
Saint-Georges, Quebec, Canada
St-Jerome Medical Research Inc.
Saint-Jérôme, Quebec, Canada
St. Michael's Hospital
Toronto, Quebec, Canada
CHRTR de Trois-Rivières
Trois-Rivières, Quebec, Canada
CSSS Vallée de l'Or
Val-d'Or, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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Related Links
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Canadian Atherosclerosis Imaging Network (CAIN) - "Hearts and Minds"
Other Identifiers
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CAIN-003
Identifier Type: -
Identifier Source: org_study_id
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