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临床试验/NCT01204645
NCT01204645Unknown不适用

Stockholmheartbank and Karolinska Cardiorenal Theme-centre, From Genome to Clinical Practice in Patients With Acute Coronary Syndrome and Impaired Kidney Function

Danderyd Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10,000
试验地点
1
主要终点
Composite

研究概览

简要总结

Chronic kidney disease (CKD) affects 10-18% of the adult population and is becoming recognized as one of the most serious disorders causing increased risk for cardiovascular disease and death. In patients with ischemic heart disease 26% have increased creatinine, which rises to 40% if patients also have diabetes mellitus. Risk increases as renal function diminishes, and just slowing the rate of decline in renal function would have a tremendous impact on health and morbidity. This association is commonly termed the Cardiorenal Syndrome, though it is caused by a much more complex interplay between major pathogenetic pathways such as glucose metabolism and diabetes, systemic and tissue inflammation, tissue metabolism, coagulation, mineral metabolism, sympathetic activation, renin-angiotensin-aldosterone system activation, endothelial dysfunction, lipid metabolism, fetal programming etc.

Karolinska Institutet recently merged basic and clinical researchers in all these fields, creating a Karolinska Kardiorenal Theme Centre; ultimately aiming to explore the syndrome and provide improved care for the individual patient.

The investigators road to success:

  • Creating a Biobank (blood, DNA, plasma) from the majority of all hosptalized patients with ACS in Stockholm county - Stockholmheartbank.
  • This Theme Center include all teaching hospitals associated with Karolinska Institutet; Danderyd University Hospital, Karolinska University Hospital and Södersjukhuset University Hospital. Together theses hospitals serve as emergency hospitals for 1.9 million people. The investigators are aiming at creating a biobank from all patients admitted for an acute coronary event (about 2.300/yr), which is a unique asset for molecular and genetic research as well as observational and intervention studies.
  • The investigators have access to the National registry with 100% coverage, that contains data on all patients admitted to Stockholms coronary care units since 1995.
  • To ensure translation in to clinical practice, most of the researchers are also MD:s, and several are clinically active.
  • The clinical network facilitates the development of novel therapies and translational research.
  • Steering groups for Education and a Clinical Practice implementation program.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients admitted to one of the four major emergency hospitals in Stockholm, for an acute coronary event.
  • All patients admitted to one of the four major emergency hospitals in Stockholm, for an elective coronary angiography

排除标准

  • Severe hemodynamic instability with the need of inotropic therapy and at the same time anemia with haemoglobin <1.1 g/dL

结局指标

主要结局

Composite

时间窗: 1 year

Combined endpoint of death, new cardiovascular event or dialysis.

次要结局

  • Renal function decline(5 year)
  • Vascular function(1 year)

研究者

发起方
Danderyd Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonas Spaak

MD PhD

Danderyd Hospital

研究点 (1)

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