Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
This trial is active, not recruiting.
|Sponsor||Canadian Atherosclerosis Imaging Network|
|Collaborator||Canadian Institutes of Health Research (CIHR)|
|Start date||January 2010|
|End date||September 2017|
|Trial size||300 participants|
|Trial identifier||NCT01353612, CAIN-003|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Edmonton, Canada||Royal Alexandra Hospital||no longer recruiting|
|Edmonton, Canada||University of Alberta Hospital||no longer recruiting|
|Calgary, Canada||Foothills Medical Centre||no longer recruiting|
|New Westminster, Canada||Royal Columbian Hospital||no longer recruiting|
|Vancouver, Canada||Interventional Cardiology Research, St. Paul's Hospital||no longer recruiting|
|Vancouver, Canada||Vancouver General Hospital||no longer recruiting|
|Victoria, Canada||Victoria Heart Institute Foundation||no longer recruiting|
|St John's, Canada||John Health Science Center||no longer recruiting|
|Halifax, Canada||Queen Elizabeth II - Health Sciences Centre||no longer recruiting|
|Cambridge, Canada||Cambridge Cardiac Care||no longer recruiting|
|Hamilton, Canada||McMaster Clinic Hamilton General Hospital||no longer recruiting|
|Kitchener, Canada||KMH Cardiology & Diagnostics Centre||no longer recruiting|
|Kitchener, Canada||St-Mary's Hospital||no longer recruiting|
|London, Canada||London Health Sciences Center||no longer recruiting|
|Mississauga, Canada||KMH Cardiology & Diagnostics Centre||no longer recruiting|
|Newmarket, Canada||Southlake Regional Health Center||no longer recruiting|
|Oshawa, Canada||Heart Care Research||no longer recruiting|
|Ottawa, Canada||University of Ottawa Heart Institute||no longer recruiting|
|Scarborough, Canada||Scarborough Cardiology Research||no longer recruiting|
|Toronto, Canada||Sunnybrook Health Science Center||no longer recruiting|
|Toronto, Canada||University Health Network||no longer recruiting|
|Chicoutimi, Canada||Complexe Hospitalier de la Sagamie||no longer recruiting|
|Fleurimont, Canada||CHUS-Hopital Fleurimont||no longer recruiting|
|Gatineau, Canada||CSSS-Hopital de Gatineau, secteur Hull||no longer recruiting|
|Greenfield Park, Canada||Viacar Recherche Clinique||no longer recruiting|
|Laval, Canada||CSSS de Laval||no longer recruiting|
|Longueuil, Canada||Hopital Pierre Boucher||no longer recruiting|
|Montreal, Canada||CHUM Hopital-Hôtel-Dieu||no longer recruiting|
|Montreal, Canada||CUSM Montreal General Hospital||no longer recruiting|
|Montreal, Canada||Hopital Sacré-Cœur de Montreal||no longer recruiting|
|Montreal, Canada||Montreal Heart Institute||no longer recruiting|
|St-Charles-Borromée, Canada||Centre Hospitalier Régional de Lanaudière||no longer recruiting|
|St-Jerome, Canada||St-Jerome Medical Research Inc.||no longer recruiting|
|St. Georges de Beauce, Canada||Centre de santé et des services sociaux de Beauce||no longer recruiting|
|Toronto, Canada||St. Michael's Hospital||no longer recruiting|
|Trois-Rivières, Canada||CHRTR de Trois-Rivières||no longer recruiting|
|Val D'Or, Canada||CSSS Vallée de l'Or||no longer recruiting|
|Saskatoon, Canada||Royal University Hospital||no longer recruiting|
|Quebec, Canada||Institut Universitaire de Cardiologie et de Pneumologie de Québec||no longer recruiting|
co-primary outcome measure - Nominal change from baseline in percent atheroma volume
time frame: 2 years
co-primary outcome measure - nominal change from baseline in carotid IMT
time frame: 2 years
cardiovascular morbidity and mortality
time frame: 5 years
Male or female participants at least 18 years old.
- 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.
|Official title||Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes|
|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.|
Call for more information