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

Sponsor
Canadian Atherosclerosis Imaging Network (Other)
Overall Status
Completed
CT.gov ID
NCT01353612
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
1,626
Enrollment
39
Locations
95
Actual Duration (Months)
41.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1626 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
    Actual Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2017
    Actual Study Completion Date :
    Dec 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. co-primary outcome measure - Nominal change from baseline in percent atheroma volume [2 years]

      intravascular ultrasound measure

    2. co-primary outcome measure - nominal change from baseline in carotid IMT [2 years]

      2D B-mode carotid ultrasound measure

    Secondary Outcome Measures

    1. cardiovascular morbidity and mortality [5 years]

      as adjudicated by a Clinical Endpoint Committee

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Royal Alexandra Hospital Edmonton Alberta Canada T5H 3V9
    2 University of Alberta Hospital Edmonton Alberta Canada T6L 5X8
    3 Foothills Medical Centre Calgary British Columbia Canada T2N 2T9
    4 Royal Columbian Hospital New Westminster British Columbia Canada V3L 3W4
    5 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
    6 Interventional Cardiology Research, St. Paul's Hospital Vancouver British Columbia Canada V6Z 1Y6
    7 Victoria Heart Institute Foundation Victoria British Columbia Canada V8R 4R2
    8 John Health Science Center St John's Newfoundland and Labrador Canada A1B 3V6
    9 Queen Elizabeth II - Health Sciences Centre Halifax Nova Scotia Canada B3H 3A7
    10 Cambridge Cardiac Care Cambridge Ontario Canada N1R 6V6
    11 McMaster Clinic Hamilton General Hospital Hamilton Ontario Canada L8L 2X2
    12 St-Mary's Hospital Kitchener Ontario Canada N2M 1B2
    13 KMH Cardiology & Diagnostics Centre Kitchener Ontario Canada N2M 5N4
    14 London Health Sciences Center London Ontario Canada N6G 2V2
    15 KMH Cardiology & Diagnostics Centre Mississauga Ontario Canada L5K 2L3
    16 Southlake Regional Health Center Newmarket Ontario Canada L3Y 2R2
    17 Heart Care Research Oshawa Ontario Canada L1J 2J9
    18 University of Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
    19 Scarborough Cardiology Research Scarborough Ontario Canada M1E 5E9
    20 Sunnybrook Health Science Center Toronto Ontario Canada M4N 3M5
    21 University Health Network Toronto Ontario Canada M5G 2C4
    22 Complexe Hospitalier de la Sagamie Chicoutimi Quebec Canada G7H 5H6
    23 CHUS-Hopital Fleurimont Fleurimont Quebec Canada J1H 5N4
    24 CSSS-Hopital de Gatineau, secteur Hull Gatineau Quebec Canada J8Y 6S9
    25 Viacar Recherche Clinique Greenfield Park Quebec Canada J4V 2G8
    26 CSSS de Laval Laval Quebec Canada H7M 3L9
    27 Hopital Pierre Boucher Longueuil Quebec Canada J4M 2X1
    28 Montreal Heart Institute Montreal Quebec Canada H1T 1C8
    29 CHUM Hopital-Hôtel-Dieu Montreal Quebec Canada H2W 1T8
    30 CUSM Montreal General Hospital Montreal Quebec Canada H3G 1A4
    31 Hopital Sacré-Cœur de Montreal Montreal Quebec Canada H4J 1C5
    32 Centre de santé et des services sociaux de Beauce Saint-Georges Quebec Canada G5Y 4T8
    33 Centre Hospitalier Régional de Lanaudière St-Charles-Borromée Quebec Canada J6E 6J2
    34 St-Jerome Medical Research Inc. St-Jerome Quebec Canada J7Z 5T3
    35 St. Michael's Hospital Toronto Quebec Canada M5B 1W8
    36 CHRTR de Trois-Rivières Trois-Rivières Quebec Canada G8Z 3R9
    37 CSSS Vallée de l'Or Val D'Or Quebec Canada J9P 3Y1
    38 Royal University Hospital Saskatoon Saskatchewan Canada S7N OW8
    39 Institut Universitaire de Cardiologie et de Pneumologie de Québec 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Canadian Atherosclerosis Imaging Network
    ClinicalTrials.gov Identifier:
    NCT01353612
    Other Study ID Numbers:
    • CAIN-003
    First Posted:
    May 13, 2011
    Last Update Posted:
    Feb 24, 2020
    Last Verified:
    Feb 1, 2020
    Additional relevant MeSH terms:
    Carotid Artery Diseases
    Atherosclerosis

    Study Results

    No Results Posted as of Feb 24, 2020