- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00448487
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Haifa, 이스라엘
- Clalit Health Services, Haifa and Western Galilee District
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death)
기간: Continuously till end of June 2008
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Continuously till end of June 2008
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Shany Blum, M.D. M.Sc., Technion, Israel Institute of Technology
- 수석 연구원: Uzi Milman, M.D., Clalit Health Services
- 수석 연구원: Chen Shapira, M.D., Clalit Health Services
- 수석 연구원: Andrew P Levy, M.D. Ph.D., Technion, Israel Institute of Technology
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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