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临床试验/NCT03105427
NCT03105427已完成不适用

Assoziationen Von Leukozyten-Sub-Populationen im Blut kardiovaskulärer Risikopatienten Mit Der Inzidenz Perioperativer kardiovaskulärer Ereignisse

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2017年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
233
试验地点
1
主要终点
Cardiovascular Events

研究概览

简要总结

The potential use of regulatory T cells as preoperative risk stratification tool is evaluated in order to improve clinical risk stratification and reduce perioperative morbidity and mortality.

详细描述

Annually, there are more than 200 million surgeries worldwide. The POISE study revealed 5% of patients undergoing a non-cardiac surgery suffer perioperative myocardial infarcts going along with a perioperative mortality rate of about 11,6%. Possibilities to preoperatively identify patients at risk are limited and prophylactic interventions are not yet established or controversial.

Selected leukocyte subpopulations have been demonstrated to be associated with higher risk for cardiovascular events.

The aim of this study is to evaluate the potential use of regulatory T cells as preoperative risk stratification tool in order to improve clinical risk stratification and reduce perioperative morbidity and mortality. Therefore, high-risk cardiovascular patients scheduled for major non-cardiac surgery will be recruited. Blood will be drawn at predefined time points before surgery and up to three days postoperatively. Leukocytes will be analyzed by flow cytometry. During 30 day follow up adverse cardiovascular events will be recorded. ECGs will be recorded preoperatively and on post-OP day 3. High-sensitive cardiac Troponin T will be measured prior to the operation and on post-OP day one to three. The patient chart will be screened for cardiovascular events up to day 30. A telephone interview will be performed to detect cardiovascular events after discharge until post-OP day 30.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • 18 years or older
  • Coronary heart disease
  • Non-cardiac surgery
  • Inpatient treatment
  • Informed consent

排除标准

  • 17 years of age or younger
  • Known pregnancy or breastfeeding
  • Missing informed consent
  • Ambulatory or day-case surgery
  • Emergency surgery
  • Acute or chronic leukemia
  • Current aplasia or leukopenia
  • Current GM-CSF treatment
  • Carotid artery surgery
  • History of splenectomy
  • Current intravenous or oral Cortisone treatment
  • History of organ transplantation
  • Current immunosuppressive medication
  • Chemotherapy completed less than 14 days ago
  • Entity which is part of the composite endpoint diagnosed within past 28 days

结局指标

主要结局

Cardiovascular Events

时间窗: 30 days postoperative

Number of participants with Cardiovascular Events defined as occurrence of Cardiac Death and/or Myocardial Ischemia and/or Myocardial Infarction and/or Myocardial Injury After Non-cardiac Surgery (MINS) and/or Embolic Stroke and/or Thrombotic Stroke recorded until postoperative day 30. Definitions according to European Perioperative Clinical Outcome-(EPCO) definitions detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days

次要结局

  • Peripheral vascular occlusion(30 days postoperative)
  • New onset atrial fibrillation(30 days postoperative)
  • Stroke(30 days postoperative)
  • Congestive heart failure(30 days postoperative)
  • Myocardial Ischemia(30 days postoperative)
  • Myocardial Infarction(30 days postoperative)
  • Cardiac death(30 days postoperative)
  • Acute kidney injury(30 days postoperative)
  • Myocardial Injury after Non-cardiac Surgery (MINS)(30 days postoperative)

研究者

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

Johann Motsch

Prof. Dr. med. habil.

University Hospital Heidelberg

研究点 (1)

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