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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01440296
• Other study ID #: CAIN-001
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2011
• Last updated: September 23, 2011
• Start date: March 2010

Study information

• Verified date: September 2011
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Disease
• Carotid Artery Diseases

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

External Links

•   Link