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临床试验/NCT04599361
NCT04599361已完成不适用

Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)

InGef - Institute for Applied Health Research Berlin GmbH1 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
385
试验地点
1
主要终点
Guideline compliance

研究概览

简要总结

Myocardial infarction and chronic coronary heart disease (cCHD) are the most frequent causes of death in Germany. Treatment options include widening of the narrowed / blocked coronary vessel via catheter and stent or bypass surgery in which the narrowed vessel sites are bridged. The "German National Disease Management Guideline on cCHD" helps doctors to decide which treatment is most appropriate for the severity of vascular damage and possible concomitant diseases of the patient. Nevertheless, there are other factors determining treatment decision. For example, the equipment or preferences of the hospital or department in which patients are admitted, play a role in the decision.

The aim of the REVASK project is to investigate whether and to what extent the collaboration of cardiology and heart surgery specialists in so-called "heart teams" influences the decision on therapy.

For this purpose, doctors and patients will be interviewed about how the treatment decision was made and how satisfied both sides are with the outcome of the treatment and the decision. In addition, claims data from several German health insurance companies (Techniker, BARMER, Betriebs- und Innungskrankenkassen) will be analyzed. Treatment data, which is documented as usual by the treating medical staff and passed on to the health insurance companies for accounting purposes, is used. Furthermore, treatment data recorded in the registers of the professional societies is analyzed.

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 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • with chronic coronary heart disease
  • and 2- or 3-vessel or main-vessel disease
  • who are being treated at one of the recruitment sites
  • with a promptly planned intervention for myocardial revascularization
  • who are insured with pre-specified German health insurance companies (BARMER or TK)

排除标准

  • 未提供

结局指标

主要结局

Guideline compliance

时间窗: 2 years

Guidelines-compliant therapy in patients with chronic CHD (2- or 3-vessel or main vessel disease) according to German National Disease Management Guideline on chronic coronary heart disease

次要结局

  • Heart teams(2 years)
  • Decision making process(2 years)
  • Patient participation(2 years)

研究者

发起方
InGef - Institute for Applied Health Research Berlin GmbH
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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