Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
- Conditions
- Atherosclerosis
- Registration Number
- NCT01353612
- Lead Sponsor
- Canadian Atherosclerosis Imaging Network
- Brief Summary
This is a prospective, multi-center imaging study expecting to enroll approximately 1350 patients scheduled for clinically-indicated coronary angiography. Following informed consent, patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up period, patients will undergo repeat coronary IVUS and standard invasive coronary angiography as well as carotid ultrasound examination.
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.
- Detailed Description
CTA and PET Substudy:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1626
- Male and female patients over the age of 18 years.
- 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
- Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who refuse to undergo a urine or serum pregnancy test immediately prior to baseline and repeat imaging evaluations The urine or serum pregnancy test must be negative prior to imaging evaluations.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method co-primary outcome measure - Nominal change from baseline in percent atheroma volume 2 years intravascular ultrasound measure
co-primary outcome measure - nominal change from baseline in carotid IMT 2 years 2D B-mode carotid ultrasound measure
- Secondary Outcome Measures
Name Time Method cardiovascular morbidity and mortality 5 years as adjudicated by a Clinical Endpoint Committee
Trial Locations
- Locations (38)
Royal Alexandra Hospital
π¨π¦Edmonton, Alberta, Canada
University of Alberta Hospital
π¨π¦Edmonton, Alberta, Canada
Foothills Medical Centre
π¨π¦Calgary, British Columbia, Canada
Royal Columbian Hospital
π¨π¦New Westminster, British Columbia, Canada
Vancouver General Hospital
π¨π¦Vancouver, British Columbia, Canada
Interventional Cardiology Research, St. Paul's Hospital
π¨π¦Vancouver, British Columbia, Canada
Victoria Heart Institute Foundation
π¨π¦Victoria, British Columbia, Canada
John Health Science Center
π¨π¦St John's, Newfoundland and Labrador, Canada
Queen Elizabeth II - Health Sciences Centre
π¨π¦Halifax, Nova Scotia, Canada
Cambridge Cardiac Care
π¨π¦Cambridge, Ontario, Canada
McMaster Clinic Hamilton General Hospital
π¨π¦Hamilton, Ontario, Canada
St-Mary's Hospital
π¨π¦Kitchener, Ontario, Canada
KMH Cardiology & Diagnostics Centre
π¨π¦Mississauga, Ontario, Canada
London Health Sciences Center
π¨π¦London, Ontario, Canada
Southlake Regional Health Center
π¨π¦Newmarket, Ontario, Canada
Heart Care Research
π¨π¦Oshawa, Ontario, Canada
University of Ottawa Heart Institute
π¨π¦Ottawa, Ontario, Canada
Scarborough Cardiology Research
π¨π¦Scarborough, Ontario, Canada
Montreal Heart Institute
π¨π¦Montreal, Quebec, Canada
Hopital SacrΓ©-CΕur de Montreal
π¨π¦Montreal, Quebec, Canada
Sunnybrook Health Science Center
π¨π¦Toronto, Ontario, Canada
Complexe Hospitalier de la Sagamie
π¨π¦Chicoutimi, Quebec, Canada
Viacar Recherche Clinique
π¨π¦Greenfield Park, Quebec, Canada
CUSM Montreal General Hospital
π¨π¦Montreal, Quebec, Canada
University Health Network
π¨π¦Toronto, Ontario, Canada
CHUS-Hopital Fleurimont
π¨π¦Fleurimont, Quebec, Canada
CHUM Hopital-HΓ΄tel-Dieu
π¨π¦Montreal, Quebec, Canada
Centre Hospitalier Régional de Lanaudière
π¨π¦St-Charles-BorromΓ©e, Quebec, Canada
St-Jerome Medical Research Inc.
π¨π¦St-Jerome, Quebec, Canada
CSSS VallΓ©e de l'Or
π¨π¦Val D'Or, Quebec, Canada
Royal University Hospital
π¨π¦Saskatoon, Saskatchewan, Canada
St. Michael's Hospital
π¨π¦Toronto, Quebec, Canada
CHRTR de Trois-Rivières
π¨π¦Trois-RiviΓ¨res, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de QuΓ©bec
π¨π¦Quebec, Canada
CSSS de Laval
π¨π¦Laval, Quebec, Canada
CSSS-Hopital de Gatineau, secteur Hull
π¨π¦Gatineau, Quebec, Canada
Hopital Pierre Boucher
π¨π¦Longueuil, Quebec, Canada
Centre de santΓ© et des services sociaux de Beauce
π¨π¦Saint-Georges, Quebec, Canada