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临床试验/NCT04053894
NCT04053894Unknown不适用

Association of PeriOPerative Aspirin-ResisTance and CardioVascular Outcome

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
220
试验地点
1
主要终点
Myocardial Injury after Non-cardiac Surgery

研究概览

简要总结

The aim of our study is to investigate the association between perioperative aspirin resistance and Myocardial Injury after Non-cardiac Surgery (MINS) in patients undergoing vascular surgery.

详细描述

Because of new surgical techniques, advanced monitoring modalities and improvements in perioperative care, perioperative mortality and morbidity have been significantly reduced in the last decades; however, patients still suffer from high perioperative mortality and morbidity, especially those with pre-existing cardiovascular diseases. Not only perioperative myocardial infarction but also myocardial injury after non-cardiac surgery, which presents without clinical symptoms, is associated with an adverse outcome. Possibilities to preoperatively identify patients at cardiovascular risk are limited and prophylactic interventions are not yet established or controversial.

Aspirin is used for primary and secondary prevention in cardiovascular diseases. New-onset increased platelet function on aspirin treatment (aspirin resistance) has been demonstrated in cardiac and vascular surgery. Yet, it has not been investigated whether a new perioperative aspirin resistance is associated with higher risk of myocardial injury after non-cardiac surgery (MINS) and cardiovascular events.

The aim of this study is to evaluate a potential association between new-onset aspirin resistance and MINS in patients undergoing vascular surgery. If there is an association of perioperative aspirin resistance and MINS during vascular surgery, the detection of perioperative aspirin resistance could be used as perioperative risk stratification tool in order to improve clinical risk stratification and reduce perioperative morbidity and mortality.

Therefore, 220 patients treated with aspirin and scheduled for vascular surgery will be recruited. Blood will be drawn at predefined time points before surgery and up to three days postoperatively. Aspirin resistance will be measured by Multiplate Analyzer prior to surgery, one hour after skin-incision, four hours after surgery and on post-OP days one and two. Adverse cardiovascular events will be recorded until 30 days post-OP. ECGs will be recorded preoperatively and on post-OP day 3. High-sensitive cardiac Troponin T will be measured prior to surgery and on post-OP days one to three. Patient charts will be screened and 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
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

  • 18 years or older
  • Preoperative aspirin treatment at least 14 days prior to surgery
  • Elective vascular surgery
  • In-patient 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
  • Current clopidogrel or non-steroidal anti-inflammatory drug treatment
  • Preoperative aspirin resistance
  • Current thrombocytopenia (<100000 platelet/µl)
  • Liver or renal failure (GOT/GPT and/or creatinine increased >2-fold)
  • Entity which is part of the composite endpoint diagnosed within past 28 days
  • Angiography without surgical intervention

结局指标

主要结局

Myocardial Injury after Non-cardiac Surgery

时间窗: 30 days postoperative

Number of participants with MINS defined as raise in postoperative hs-cTNT (high sensitivity cardiac troponin T) judged due to myocardial ischemia detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days.

次要结局

  • New-onset atrial fibrillation(30 days postoperative)
  • Composite of Cardiovascular Events(30 days postoperative)
  • Peripheral vascular occlusion(30 days postoperative)
  • Mesenteric ischemia(30 days postoperative)
  • Congestive heart failure(30 days postoperative)
  • Myocardial Ischemia(30 days postoperative)
  • Stroke(30 days postoperative)
  • Cardiac death(30 days postoperative)
  • Myocardial Infarction(30 days postoperative)
  • Length of intensive care unit stay(30 days postoperative)
  • Length of hospital stay(30 days postoperative)

研究者

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

Jan Larmann

Attending Anesthesiologist

University Hospital Heidelberg

研究点 (1)

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