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临床试验/NCT00872456
NCT00872456已完成不适用

The ADHOC Project: Associations Between Diabetes Care and Haptoglobin Genotype On outComes

Clalit Health Services0 个研究点目标入组 3,054 人开始时间: 2005年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,054
主要终点
Composite of major CVD events (non fatal MI, Stroke and CVD death)

研究概览

简要总结

The ADHOC Cohort comprised 3044 DM individuals, treated in 47 CHS primary care clinics, that underwent haptoglobin genotyping between 2 march, 2005 and 26 September 2006. Individuals were eligible for inclusion if they had DM and were 55 years of age or older. All treatment decisions, regarding all aspects of care and follow-up of the study participants, remained at the discretion of the individual's primary care physician, who was blinded to the individual's Hp type. Hp distribution was: Hp 1-1 285 (9.4%); Hp 2-1 1248 (41.0%); Hp 2-2 1511 (49.6%).

Hypothesis: strict glucose control (HbA1c<7%) reduces the rate of cardiovascular events only to diabetic patients with the Hp 2-2 phenotype. We also postulated that, since Hp 2-2 DM individuals are at an increased genetic susceptibility for cardiovascular disease (CVD), this unique cohort merits an investigation on the associations between various CVD risk variables and CVD events and establish whether any evident association was dependent of the individual's Hp type.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic patients
  • 55 years old or older at the time of ICARE initiation.
  • Known haptoglobin genotype
  • Signed informed consent for ICARE study and registry

排除标准

  • 未提供

结局指标

主要结局

Composite of major CVD events (non fatal MI, Stroke and CVD death)

时间窗: Data retrived continuously till end of 2015

Clinical data (eg. BP, weight, smoking, etc) medications use, Lab tests and reports on CVD events will be centrally collected from patient's records and Hospital admission summaries. Admission summaries are retrieved using the computerized systems of Clalit Health Services assuring that whenever a patient in the registry is hospitalized the admission summary is retrieve. An events adjudication committee will assess each event in a blinded fashion to determine the nature of the events.

次要结局

  • Non cardiovascular death(Data retrived continuously till end of 2015)
  • Revascularization procedures(Data retrived continuously till end of 2015)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Uzi Milman

Principal Investigator

Clalit Health Services

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