Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

This study is currently recruiting participants.
Verified July 2011 by Canadian Atherosclerosis Imaging Network
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Canadian Atherosclerosis Imaging Network
ClinicalTrials.gov Identifier:
NCT01353612
First received: May 12, 2011
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

This is a prospective, multi-center imaging study expecting to enroll approximately 2000 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.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

Resource links provided by NLM:


Further study details as provided by Canadian Atherosclerosis Imaging Network:

Estimated Enrollment: 2000
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with clinical indication for coronary angiography

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353612

Contacts
Contact: Jean-Claude Tardif, MD 514-376-3330 ext 3612 jean-claude.tardif@icm-mhi.org

  Hide Study Locations
Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
Foothills Medical Centre Recruiting
Calgary, British Columbia, Canada, T2N 2T9
Royal Columbian Hospital Recruiting
New Westminster, British Columbia, Canada, V3L 3W4
Interventional Cardiology Research, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Victoria Heart Institute Foundation Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
John Health Science Center Recruiting
St John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Queen Elizabeth II - Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Cambridge Cardiac Care Recruiting
Cambridge, Ontario, Canada, N1R 6V6
McMaster Clinic Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
KMH Cardiology & Diagnostics Centre Recruiting
Kitchener, Ontario, Canada, N2M 5N4
St-Mary's Hospital Recruiting
Kitchener, Ontario, Canada, N2M 1B2
London Health Sciences Center Recruiting
London, Ontario, Canada, N6G 2V2
KMH Cardiology & Diagnostics Centre Recruiting
Mississauga, Ontario, Canada, L5K 2L3
Southlake Regional Health Center Recruiting
Newmarket, Ontario, Canada, L3Y 2R2
Heart Care Research Recruiting
Oshawa, Ontario, Canada, L1J 2J9
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Scarborough Cardiology Research Recruiting
Scarborough, Ontario, Canada, M1E 5E9
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Sunnybrook Health Science Center Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Complexe Hospitalier de la Sagamie Recruiting
Chicoutimi, Quebec, Canada, G7H 5H6
CHUS-Hopital Fleurimont Recruiting
Fleurimont, Quebec, Canada, J1H 5N4
CSSS-Hopital de Gatineau, secteur Hull Recruiting
Gatineau, Quebec, Canada, J8Y 6S9
Viacar Recherche Clinique Recruiting
Greenfield Park, Quebec, Canada, J4V 2G8
CSSS de Laval Recruiting
Laval, Quebec, Canada, H7M 3L9
Hopital Pierre Boucher Recruiting
Longueuil, Quebec, Canada, J4M 2X1
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Tardif, MD     514-376-3330 ext 3612        
Principal Investigator: Jean-Claude Tardif, MD            
CHUM Hopital-Hôtel-Dieu Recruiting
Montreal, Quebec, Canada, H2W 1T8
Hopital Sacré-Cœur de Montreal Recruiting
Montreal, Quebec, Canada, H4J 1C5
CUSM Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Centre Hospitalier Régional de Lanaudière Recruiting
St-Charles-Borromée, Quebec, Canada, J6E 6J2
St-Jerome Medical Research Inc. Recruiting
St-Jerome, Quebec, Canada, J7Z 5T3
Centre de santé et des services sociaux de Beauce Recruiting
St. Georges de Beauce, Quebec, Canada, G5Y 4T8
St. Michael's Hospital Recruiting
Toronto, Quebec, Canada, M5B 1W8
CHRTR de Trois-Rivières Recruiting
Trois-Rivières, Quebec, Canada, G8Z 3R9
CSSS Vallée de l'Or Recruiting
Val D'Or, Quebec, Canada, J9P 3Y1
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N OW8
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec Recruiting
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Canadian Atherosclerosis Imaging Network
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Jean-Claude Tardif, MD Montreal Heart Institute
  More Information

No publications provided

Responsible Party: Dr. Jean-Claude Tardif, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01353612     History of Changes
Other Study ID Numbers: CAIN-003
Study First Received: May 12, 2011
Last Updated: July 12, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013