Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients
ICARER
Prospective Observational Study to Asses the Incidence of CVD Complications in Diabetic Patients Pre-stratified by Haptoglobin Phenotype From the I CARE Registry
1 other identifier
observational
3,054
1 country
1
Brief Summary
3054 diabetic patients were screened for Haptoglobin Phenotype as part of the ICARE study (NCT00220831) and composite the I CARE Registry, 1434 Hp 2-2 patients were treated as part of the I CARE study with vitamin E vs. Placebo, this study was recently terminated due to significant differences between the groups and data was sent to publication. All other patients were passively followed since April 2005 for cardiovascular events. We have decided to continue and follow these patients till end of December 2007 to determine the incidence of CVD in theses patients which are pre stratified by Haptoglobin Phenotype.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2005
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 14, 2007
CompletedFirst Posted
Study publicly available on registry
March 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJune 12, 2015
June 1, 2015
3.2 years
March 14, 2007
June 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death)
Continuously till end of June 2008
Eligibility Criteria
patients recruited from primary care clinics. all are diabetic patients 55 years old or older.
You may qualify if:
- Diabetic patients aged 55 and above
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Shany Blumlead
- Clalit Health Servicescollaborator
Study Sites (1)
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shany Blum, M.D. M.Sc.
Technion, Israel Institute of Technology
- PRINCIPAL INVESTIGATOR
Uzi Milman, M.D.
Clalit Health Services
- PRINCIPAL INVESTIGATOR
Chen Shapira, M.D.
Clalit Health Services
- PRINCIPAL INVESTIGATOR
Andrew P Levy, M.D. Ph.D.
Technion, Israel Institute of Technology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Adjunct assistant professor
Study Record Dates
First Submitted
March 14, 2007
First Posted
March 16, 2007
Study Start
April 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
June 12, 2015
Record last verified: 2015-06