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临床试验/NCT02122497
NCT02122497Unknown不适用

The Use of Cardiovascular Biomarkers in Abdominal Aortic Surgery: Possibility of Risk Assessment and Stratification

Prim PD Dr Afshin Assadian1 个研究点 分布在 1 个国家目标入组 500 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
发起方
入组人数
500
试验地点
1
主要终点
cardiovascular morbidity and mortality

研究概览

简要总结

The aim of the present study is the evaluation of cardiovascular biomarkers in patients with abdominal aortic aneurysms (AAA) or abdominal aortic occlusive disease AOD) undergoing open (OR) or endovascular aortic repair (EVAR) with regards to short- and long-term outcome.

By blood collection and measurement of the serum biomarkers Copeptin, N-terminal- pro Brain Natriuretic Peptide (NT-proBNP), cardiac Troponin I (cTnI), high sensitive Troponin T (hs-cTnT) and C-reactive Protein (CRP) we expect an improvement of patients stratification by assessment of cardiac stress tolerance. Data gathered may help to simplify the decision whether an open or endovascular approach for abdominal aortic repair (OR and EVAR) should be performed.

Study Hypothesis:

The evaluation of the predictive value of cardiovascular biomarkers (Copeptin, NT-proBNP, hsTnT, cTnI, CRP) improve patient stratification and selection of surgical treatment.

详细描述

Background:

The prevalence of coronary artery disease (CAD) in patients with aneurysmal or occlusive disease of the aorta is high: more than 50 percent of patients suffering from peripheral arterial occlusive disease (PAOD) or abdominal aortic aneurysm (AAA) do also have coronary artery disease. As a result, cardiovascular disease is the leading cause of morbidity and mortality in patients undergoing aortic surgery.

Identifying patients at increased risk of cardiac complications following major vascular surgery is also part of the decision-finding process when patients are assigned to open or endovascular surgery. The 30-day mortality rate for elective open aneurysm repair (OR) is estimated to be 4 to 8%, while endovascular aneurysm repair (EVAR) has a perioperative risk of 1.2 to 1.6%. However, the early survival advantage of patients undergoing EVAR disappears with time and all-cause mortality is similar for EVAR and open repair at late follow-up. Patients treated by EVAR show a higher number of complications and reinterventions, and a significant proportion of late deaths after EVAR are due to aneurysm rupture.

Therefore, patients who need abdominal aortic surgery are required to undergo a thorough medical examination, on the one hand to assess cardiac capacity, on the other hand to estimate life expectancy. Current recommendations for the preoperative management of patients undergoing major non-cardiac vascular surgery include physical examination and routine performance of electrocardiogram and echocardiogram as part of a cardiovascular evaluation. However, guidelines do not include routine screening with cardiac enzymes or cardiac stress markers.

Biomarkers:

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

  • abdominal aortic aneurysm
  • peripheral aortic occlusive disease
  • age > 18 years
  • approval to participate

排除标准

  • absence of clearing for surgery
  • canceled surgery
  • unability or refusal to participate
  • lack of complete follow-up

结局指标

主要结局

cardiovascular morbidity and mortality

时间窗: up to five years

次要结局

  • all cause mortality(up to five years)

研究者

发起方
Prim PD Dr Afshin Assadian
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prim PD Dr Afshin Assadian

Prim PD Dr

Wilhelminenspital Vienna

研究点 (1)

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