Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
1 other identifier
observational
1,626
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 12, 2011
CompletedFirst Posted
Study publicly available on registry
May 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 24, 2020
February 1, 2020
7.9 years
May 12, 2011
February 20, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
co-primary outcome measure - Nominal change from baseline in percent atheroma volume
intravascular ultrasound measure
2 years
co-primary outcome measure - nominal change from baseline in carotid IMT
2D B-mode carotid ultrasound measure
2 years
Secondary Outcomes (1)
cardiovascular morbidity and mortality
5 years
Eligibility Criteria
Patients with clinical indication for coronary angiography
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6L 5X8, Canada
Foothills Medical Centre
Calgary, British Columbia, T2N 2T9, Canada
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W4, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Interventional Cardiology Research, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2, Canada
John Health Science Center
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Queen Elizabeth II - Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
Cambridge Cardiac Care
Cambridge, Ontario, N1R 6V6, Canada
McMaster Clinic Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
St-Mary's Hospital
Kitchener, Ontario, N2M 1B2, Canada
KMH Cardiology & Diagnostics Centre
Kitchener, Ontario, N2M 5N4, Canada
London Health Sciences Center
London, Ontario, N6G 2V2, Canada
KMH Cardiology & Diagnostics Centre
Mississauga, Ontario, L5K 2L3, Canada
Southlake Regional Health Center
Newmarket, Ontario, L3Y 2R2, Canada
Heart Care Research
Oshawa, Ontario, L1J 2J9, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Scarborough Cardiology Research
Scarborough Village, Ontario, M1E 5E9, Canada
Sunnybrook Health Science Center
Toronto, Ontario, M4N 3M5, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, G7H 5H6, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
CSSS-Hopital de Gatineau, secteur Hull
Gatineau, Quebec, J8Y 6S9, Canada
Viacar Recherche Clinique
Greenfield Park, Quebec, J4V 2G8, Canada
CSSS de Laval
Laval, Quebec, H7M 3L9, Canada
Hopital Pierre Boucher
Longueuil, Quebec, J4M 2X1, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
CHUM Hopital-Hôtel-Dieu
Montreal, Quebec, H2W 1T8, Canada
CUSM Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Hopital Sacré-Cœur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
Centre Hospitalier Régional de Lanaudière
Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
Centre de santé et des services sociaux de Beauce
Saint-Georges, Quebec, G5Y 4T8, Canada
St-Jerome Medical Research Inc.
Saint-Jérôme, Quebec, J7Z 5T3, Canada
St. Michael's Hospital
Toronto, Quebec, M5B 1W8, Canada
CHRTR de Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9, Canada
CSSS Vallée de l'Or
Val-d'Or, Quebec, J9P 3Y1, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N OW8, Canada
Related Links
Biospecimen
samples stored for potential correlation with imaging and cardiovascular outcomes endpoints in subset of patients (optional)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean-Claude Tardif, MD
Montreal Heart Institute
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2011
First Posted
May 13, 2011
Study Start
January 1, 2010
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
February 24, 2020
Record last verified: 2020-02