ICARER: Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients

Sponsor

Dr. Shany Blum (Other)

Overall Status

Completed

CT.gov ID

NCT00448487

Collaborator

Clalit Health Services (Other)

3,054

Enrollment

Location

Duration (Months)

80.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Cardiovascular Disease Myocardial Infarction

Detailed Description

3054 diabetic patients from Clalit Medical Services 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.

During the follow up period of the I CARE study all 3054 registry patients were followed in a passive way, which means that the patients were not called for follow up visits but the reports for CVD events were centrally collected from patient's Hospital admission summaries. Admission summaries were collected using the computerized systems of the Clalit Health Services assuring that when ever a patient in the registry is hospitalized for what ever reason the study coordination them would be aware of that and receive the admission summary. An events adjudication committee adjudicated each event in a blinded fashion to determine the nature of the events.

1434 patients who were treated by vitamin E or placebo in the I CARE study were also followed by follow-up telephone calls.

once I CARE study was officially terminated we have decided to continue and follow the whole 3054 registry patients in the same manner to complete a nearly 3 year follow up to determine in a prospective manner the incidence of CVD events in Diabetic patients which were pre-stratified by Haptoglobin type.

Study Design

Study Type:

Observational

Actual Enrollment :

3054 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Study to Asses the Incidence of CVD Complications in Diabetic Patients Pre-stratified by Haptoglobin Phenotype From the I CARE Registry

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death) [Continuously till end of June 2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clalit Health Services, Haifa and Western Galilee District	Haifa		Israel

Sponsors and Collaborators

Dr. Shany Blum
Clalit Health Services

Investigators

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