Clinical trial NCT01353612: Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
Official title: Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: Canadian Atherosclerosis Imaging Network
Sponsor class: NETWORK
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-05-13
Enrollment: 1626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical indication for coronary angiography

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion 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.

Primary outcomes:
measure: co-primary outcome measure - Nominal change from baseline in percent atheroma volume
timeFrame: 2 years
measure: co-primary outcome measure - nominal change from baseline in carotid IMT
timeFrame: 2 years
Secondary outcomes:
measure: cardiovascular morbidity and mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: British Columbia
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Interventional Cardiology Research, St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: St John's
country: Canada
facility: John Health Science Center
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II - Health Sciences Centre
state: Nova Scotia
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Clinic Hamilton General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: St-Mary's Hospital
state: Ontario
city: Kitchener
country: Canada
facility: KMH Cardiology & Diagnostics Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Mississauga
country: Canada
facility: KMH Cardiology & Diagnostics Centre
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Oshawa
country: Canada
facility: Heart Care Research
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Cardiology Research
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Center
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Chicoutimi
country: Canada
facility: Complexe Hospitalier de la Sagamie
state: Quebec
city: Fleurimont
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Gatineau
country: Canada
facility: CSSS-Hopital de Gatineau, secteur Hull
state: Quebec
city: Greenfield Park
country: Canada
facility: Viacar Recherche Clinique
state: Quebec
city: Laval
country: Canada
facility: CSSS de Laval
state: Quebec
city: Longueuil
country: Canada
facility: Hopital Pierre Boucher
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: CHUM Hopital-Hôtel-Dieu
state: Quebec
city: Montreal
country: Canada
facility: CUSM Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacré-Cœur de Montreal
state: Quebec
city: Saint-Georges
country: Canada
facility: Centre de santé et des services sociaux de Beauce
state: Quebec
city: St-Charles-Borromée
country: Canada
facility: Centre Hospitalier Régional de Lanaudière
state: Quebec
city: St-Jerome
country: Canada
facility: St-Jerome Medical Research Inc.
state: Quebec
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Quebec
city: Trois-Rivières
country: Canada
facility: CHRTR de Trois-Rivières
state: Quebec
city: Val D'Or
country: Canada
facility: CSSS Vallée de l'Or
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
affiliation: Montreal Heart Institute
name: Jean-Claude Tardif, MD
role: STUDY_CHAIR
References: