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临床试验/NCT02276950
NCT02276950进行中(未招募)不适用

HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery (HARTROCS)

Ulrik Sartipy, MD, PhD0 个研究点目标入组 150,000 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
150,000
主要终点
All-cause mortality

研究概览

简要总结

The overall project aim is to study risk and outcomes following cardiac surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.

详细描述

The purpose of this research project is to study risks and outcomes in patients who underwent cardiac surgery. We aim to establish a fundament for the conduct of nationwide population-based studies by linking patient-level data from the Swedish Heart Surgery Register (SWEDEHEART), the National Patient Register, the Cause of Death Register, the National Diabetes Register, the Swedish Renal Registry, the Prescribed Drug Register, and the 2nd version of the Swedish-Danish Scandinavian Donations and Transfusions database. Cross-linking patient-level data is possible through the Personal Identity Number assigned to every individual who has resided in Sweden on a permanent basis. The Swedish Personal Identity Number is the unique identifier in all national registers.

Specifically, we aim:

  1. To assess the importance of chronic kidney disease for prognosis after CABG.
  2. To assess the consequences of acute kidney injury following CABG.
  3. To analyze the prognosis in patients with depression prior to CABG.
  4. To study risks and benefits of blood transfusions in cardiac surgery.
  5. To study the risks associated with diabetes mellitus in cardiac surgery with special reference to type of diabetes (type 1 and type 2) and glycaemic control and duration of disease.
  6. To investigate the long-term impact of different surgical strategies (e.g. use of multiple arterial grafts or non-use of cardio-pulmonary bypass) during CABG.
  7. To analyze prognosis in relevant sub-populations undergoing CABG (e.g. patients 50 years or younger, possible differences between men and women, and patients with heart failure with preserved vs. reduced ejection fraction).
  8. To investigate survival and morbidity in patients between 50 and 69 years undergoing aortic valve replacement with particular reference to prosthesis type (mechanical vs. biological).
  9. To analyze the association between socioeconomic factors and prognosis in patients undergoing cardiac surgery.
  10. To investigate factors related to durability of bioprosthetic aortic heart valves.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients who underwent cardiac surgery in Sweden during the study period

排除标准

  • 未提供

结局指标

主要结局

All-cause mortality

时间窗: 15 years

次要结局

  • End-Stage Renal Disease(15 years)
  • Repeat Revascularization(15 years)
  • Cardiovascular Death(15 years)
  • Aortic valve reoperation(15 years)
  • Composite(15 years)
  • Myocardial Infarction(15 years)
  • Heart Failure(15 years)
  • Stroke(15 years)

研究者

发起方
Ulrik Sartipy, MD, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ulrik Sartipy, MD, PhD

MD, PhD

Karolinska University Hospital

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