跳至主要内容
临床试验/NCT04292652
NCT04292652招募中不适用

Treatment With Endovascular or Open Repair for AAA - Comparison of Perioperative Myocardial Injury Detected With Holter-ECG and Troponin

Göteborg University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Ischemic myocardial injury

研究概览

简要总结

Comparison of elective infrarenal aneurysm surgery with open and endovascular technique, respectively, for subclinical ischemic myocardial injury detectable with troponin T and/or 3-channel Holter ECG with ST analysis

详细描述

Background: Traditional open surgery for abdominal aortic aneurysm (AAA) is burdened with complication risk from several organ systems, and also mortality figures of 3.5 - 5.5%. Over 50% of early mortality can be attributed to cardiovascular complications. Myocardial infarction is the dominant organ-specific cause of both early and late mortality in patients operated on for AAA. Endovascular surgery (EndoVascular Aortic Repair, EVAR) was developed during the 90's as an alternative method that is considered less invasive and more well-tolerated from a cardiovascular perspective.

Troponin T is a very sensitive and specific marker that predicts mortality in patients with acute symptoms of unstable angina and/or heart attack. Previous studies have also shown a high incidence of elevated troponin levels in patients who underwent major surgical procedures, especially vascular surgery, even in the absence of corresponding clinical or ECG-related symptoms of cardiac muscle injury. Several studies have also demonstrated that elevated troponin levels after surgery predict increased morbidity and mortality both short-term and long-term.

Objective

To prospectively compare elective open and endovascular surgery of AAA with respect to myocardial injury detectable with troponin T. Furthermore, to compare open and endovascular AAA surgery for the total number of periods of oxygen deficiency in cardiac muscle during and at early stages after surgery using a special ECG method (48-hour 3-channel Holter ECG with ST analysis).

Main aim of the study: To assess whether EVAR induce less myocardial injury compared with open repair for AAA.

Significance: Myocardial infarction is the predominant cause of mortality in open surgical procedure for AAA. In several previous studies, troponin T rise has been associated with impaired both short-term and long-term prognosis in elderly patients undergoing major elective surgery. This study may provide information on whether the endovascular technique provides a reduction in myocardial injury, measured as elevated troponin T or myocardial ischemia with 3-channel Holter ECG. In this way, our study can provide improved decision support in the choice of the most appropriate treatment method in the individual case.

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

  • Accepted for AAA surgery of either one of the operative techniques

排除标准

  • High anesthesiological risk
  • Preoperative cardiac condition with EF < 25 or ischemic signs on preoperative evaluation
  • Severe renal insufficiency with s-creatinine >200

结局指标

主要结局

Ischemic myocardial injury

时间窗: Perioperative

Perioperative myocardial injury induced by the procedure

次要结局

未报告次要终点

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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