Magnetic Resonance Imaging (MRI) Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes
| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 22, 2011 |
| Last Updated Date | September 23, 2011 |
| Start Date ICMJE | March 2010 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01440296 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Magnetic Resonance Imaging (MRI) Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes |
| Official Title ICMJE | Magnetic Resonance Imaging (MRI) Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | patients from tertiary care centre |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 500 |
| Completion Date | Not Provided |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | Canada |
| Administrative Information | |
| NCT Number ICMJE | NCT01440296 |
| Other Study ID Numbers ICMJE | CAIN-001 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Dr. Alan Moody, Sunnybrook Health Sciences Centre |
| Study Sponsor ICMJE | Sunnybrook Health Sciences Centre |
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) |
| Investigators ICMJE | Not Provided |
| Information Provided By | Sunnybrook Health Sciences Centre |
| Verification Date | September 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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