Magnetic Resonance Imaging (MRI) Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT01440296
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
500
1

Study Details

Study Description

Brief Summary

The Canadian Atherosclerosis Imaging Network (CAIN) is a pan-canadian imaging network funded through grants from the Canadian Foundation for Innovation (CFI) and the Canadian Institutes of Health Research (CIHR). This unique research network is focused on the pathobiology of atherosclerotic disease as it pertains to the coronary and carotid circulations. The CAIN research program involves the creation of a unique national network focused on in vivo imaging of vessel wall disease, combined with imaging of occult end-organ disease as well as the acquisition of clinical and pathological end points. CAIN enables unprecedented cross-sectional and longitudinal clinical studies of patients with atherosclerotic disease in coronary or carotid vascular beds, and has established an international resource for studying the natural history, progression, regression and novel therapeutic interventions aimed at atherosclerosis.

The primary outcome of this study is to accurately characterise carotid plaque morphology in non-surgical patients with mild to severe (30-95%) carotid disease. The investigators will also assess evidence of ischaemic brain disease. Patients will undergo MRI scanning of the brain and carotid and US scanning of the carotid at baseline and thereafter at 1 and 2 years or sooner if presenting clinically in order to monitor the natural history of carotid atherosclerosis and its effect on end-organ brain disease.

Patients will consent to baseline scanning and follow up at 1 and 2 years, and databasing of clinical and imaging data. After each imaging session images will be processed, stored locally and also sent to a central repository. 500 patients will be recruited over a 2 year period in anticipation of study completion within 4 years.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Magnetic Resonance Imaging (MRI) Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes
    Study Start Date :
    Mar 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • male and female patients over the age of 18 years.

      • written informed consent (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific procedures.

      • patient with mild to severe carotid artery disease

      Exclusion Criteria:
      • any condition that would contra-indicate Magnetic Resonance Imaging or administration of contrast agent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

      Sponsors and Collaborators

      • Sunnybrook Health Sciences Centre
      • Canadian Institutes of Health Research (CIHR)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Dr. Alan Moody, Dr, Sunnybrook Health Sciences Centre
      ClinicalTrials.gov Identifier:
      NCT01440296
      Other Study ID Numbers:
      • CAIN-001
      First Posted:
      Sep 26, 2011
      Last Update Posted:
      Sep 26, 2011
      Last Verified:
      Sep 1, 2011
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Sep 26, 2011