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临床试验/NCT07599540
NCT07599540进行中(未招募)不适用

Prognostic Markers of Cardiovascular Risk in Peripheral Artery Disease Patients Undergoing Endovascular Revascularisation

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
500
试验地点
1

研究概览

简要总结

This study will investigate heart-related complications in patients with peripheral arterial disease (PAD) undergoing endovascular revascularization procedures to improve blood flow in the legs. Previous studies have shown that some patients develop silent heart injury after these procedures, even without symptoms, and that this may be associated with worse long-term outcomes.

Approximately 500 patients will be included in the study. Blood tests for cardiac biomarkers, including high-sensitivity troponin and NT-proBNP, will be performed before and after the procedure. Participants will also undergo ultrasound examination of the heart to assess heart function, including advanced measures that may detect early or subtle heart damage. In addition, heart rate variability will be measured using a short electrocardiogram recording.

Patients will be followed for 30 days and 1 year after the procedure to assess the occurrence of major cardiovascular events, limb-related complications, and death. Additional blood samples will be collected and stored for future analysis of inflammation, oxidative stress, and genetic markers that may help explain the mechanisms associated with heart injury and prognosis in these patients.

详细描述

According to the recommendations of the European Society of Cardiology, serial measurement of cardiac troponin before and after procedures with moderate or high peri-procedural risk is recommended in cardiovascular patients undergoing surgery or interventions, including lower extremity revascularization procedures. Peri-operative myocardial infarction/injury (PMI) is defined as an increase in troponin levels on postoperative day 1 or 2 above the reference range compared with the pre-procedural value. Most patients with PMI do not present with typical ECG changes or clinical symptoms suggestive of myocardial ischemia. Identification of PMI is clinically important, as studies have shown that PMI predicts worse cardiovascular outcomes. Patients with PMI have higher 30-day and 1-year mortality rates and a higher incidence of major adverse cardiovascular events. The incidence of PMI in patients with peripheral arterial disease (PAD) is approximately 20%, which is higher than that observed after non-cardiac surgery in the general population.

Only two studies have reported myocardial injury after endovascular revascularization treatment for peripheral arterial disease, specifically myocardial injury after non-cardiac surgery (MINS), which, unlike PMI, excludes non-ischemic causes. In patients with critical limb ischemia, PMI occurred in 25.5% of patients after the procedure and was associated with a 2.4-fold increase in mortality and a 2.9-fold increase in major adverse cardiovascular events within one year. In patients with intermittent claudication, PMI occurred in 2% of patients and was likewise associated with a worse prognosis, with a higher incidence of cardiac death, myocardial infarction, and urgent revascularization during a 2.4-year follow-up period (7% vs. 30.8%).

Current risk assessment recommendations prior to revascularization procedures also include measurement of BNP or NT-proBNP (N-terminal pro-B-type natriuretic peptide). Elevated levels are associated with poorer cardiovascular prognosis and may additionally help identify previously undiagnosed heart failure in patients with PAD. Previous studies have shown NT-proBNP to be a better predictor of perioperative cardiovascular risk than parameters obtained from standard echocardiographic examination.

However, emerging evidence suggests that newer and more advanced echocardiographic parameters, capable of detecting subclinical myocardial dysfunction, may provide additional prognostic value in cardiovascular risk stratification. In patients undergoing major non-cardiac surgery under general anesthesia, impaired preoperative left ventricular global longitudinal strain (LVGLS) demonstrated independent and incremental prognostic value for predicting mortality, acute coronary syndrome, and MINS within 30 days after surgery, whereas left ventricular ejection fraction did not.

Prognostic assessment in patients with PAD may potentially be further improved by evaluation of myocardial work (MW) echocardiographic parameters, although data on this topic are currently lacking. Furthermore, it remains unknown whether endovascular revascularization procedures influence heart rate variability (HRV), which is also an established prognostic marker.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with Peripheral Arterial Disease admitted to the University Medical Centre Ljubljana for endovascular treatment of lower extremity peripheral arterial disease.
  • Ability and willingness to provide written informed consent after explanation of the purpose and procedures of the study.

排除标准

  • Active malignant disease.
  • End-stage renal disease requiring dialysis treatment.
  • Previous enrollment in the study.

研究者

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

Martina Turk Veselič

PhD, MD, specialist of cardiology, vascular medicine and internal medicine

University Medical Centre Ljubljana

研究点 (1)

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