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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00448487 |
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Date of registration:
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14/03/2007 |
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Primary sponsor: |
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Public title:
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Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients
ICARE Registry |
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Scientific title:
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Prospective Observational Study to Asses the Incidence of CVD Complications in Diabetic Patients Pre-Stratified by Haptoglobin Phenotype From the I CARE Registry |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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3054 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00448487 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Israel
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Contacts
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Name:
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Chen Shapira, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Name:
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Uzi Milman, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Name:
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Andrew P Levy, M.D. Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Technion, Israel Institute of Technology |
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Name:
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Shany Blum, M.D. M.Sc. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Technion, Israel Institute of Technology |
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Key inclusion & exclusion criteria
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These are the same patients as in I CARE registry so the criteria are the same as was for
I CARE study Recruitment phase.
Inclusion Criteria:
- Diabetic patients aged 55 and above
Exclusion Criteria:
- Patient who takes antioxidant treatment will be asked to stop, or can't be included
in the study
- Patients who had a CVD incident (MI, Stroke, TIA), Unstable angina pectoris,
Uncontrolled HTN, will have to wait a month after stabilization to be included in the
study
- Allergy to Vitamin E
Age minimum:
55 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiovascular Disease
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Diabetes
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Primary Outcome(s)
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same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death)
[Time Frame: Continuously till end of June 2008]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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