跳至主要内容
临床试验/NCT05293067
NCT05293067进行中(未招募)不适用

Troponin In Carotid Revascularization

University of Belgrade2 个研究点 分布在 1 个国家目标入组 527 人开始时间: 2023年6月1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
527
试验地点
2
主要终点
The incidence of myocardial injury

研究概览

简要总结

Patients undergoing carotid revascularization procedures are at increased risk for the development of short- and long-term cardiac complications. Increased values of high-sensitive troponin may be useful in a timely selection of those patients. Still, contemporary literature doesn't provide enough data to answer the following questions: "Can high-sensitive troponin predict adverse cardiac outcomes perioperatively in carotid surgery?", "Should these cardiac biomarkers be routinely sampled in all patients undergoing carotid revascularization?" and "Can elevated levels of high-sensitive troponin preoperatively designate patients in whom the risk of surgical treatment (at a given moment) is greater than the benefit of the surgery?".

详细描述

The aims of the study are: 1) to determine the incidence of elevated troponin levels pre- and postoperatively in patients undergoing CEA/CAS; 2) to assess whether elevated troponin levels pre- and postoperatively can predict the occurrence of myocardial infarction and death in these patients; 3) to demonstrate whether routine pre- and postoperative troponin measurement is justified in all or only in a particular subpopulation of patients, and 4) to assess whether, in this regard, a difference between patients undergoing CEA and CAS procedures exists.

A prospective, multicenter cohort study would include approximately 240 consecutive patients undergoing CEA/CAS procedures, under the conditions of regional/general and local anesthesia, during the period from April, to August 2022. Patients admitted due to emergency procedure for immediate surgical treatment (the same day), patients with preoperative anemia (due to any reason, hemoglobin level < 10 g/dL), in whom concomitant or "staged" cardiac surgery or vascular procedure is planned, who had an acute coronary event in the previous 3 months, patients undergoing multiple CEA/CAS during the study period, as well as those patients with conditions that may lead to increased troponin levels (end-stage kidney disease, sepsis, acute pericarditis and myocarditis, advanced heart failure, chemotherapy, systemic inflammatory diseases, and critical limb ischemia) would be excluded from the study. Using a pre-designed questionnaire, standard demographic and clinical data (related to comorbidities, chronic therapy, habits, previous surgery, and characteristics of carotid disease) would be collected. Intraoperative data (type of carotid intervention, type of anesthesia technique, and shunt placement), as well as data regarding the postoperative course, would be obtained from the database implemented in daily practice and patients' medical records. High-sensitive troponin would be measured in all patients, according to the following plan: 1) preoperatively - one day before the planned intervention and 2) postoperatively - 8 hours after the operation and on the first day after the operation. Troponin samples would be frozen and analyzed only after the patient's hospital discharge. Also, ECG would be recorded immediately following troponin measurement (a day before the planned intervention, 8 hours and 24 hours after the intervention). Patients operated on at the Clinic for Vascular and Endovascular Surgery of the University Clinical Center of Serbia would be operated under the conditions of regional anesthesia - a combination of deep and superficial cervical plexus block (which is a regular practice at this Institution), or local infiltrative anesthesia (for CAS procedures), while patients in other Hospital would be treated under the conditions of general anesthesia (Collaborators - to be defined). Clinical outcomes of interest: myocardial injury, myocardial infarction, stroke, cardiac-related death, and the all-cause mortality, would be recorded perioperatively, until hospital discharge (2 days following the procedure). Myocardial infarction, stroke, cardiac-related death, and the all-cause mortality would be recorded preoperatively and up to 2 days following the procedure, one month after, one and two years following surgery (at regular postoperative check-ups or by telephone interview with the patient, or a member of his family). Myocardial injury would be defined in accordance with the current Fourth Universal Definition of Myocardial Infarction, published by the European Society of Cardiology, as the existence of at least one elevated troponin value above the 99th percentile of the upper reference limit. In accordance with the same recommendations, acute myocardial infarction would be defined as the existence of an increase and/or decrease in troponin levels and clinical signs of acute myocardial ischemia. The indication for surgery or stenting procedure would be made based on the European Society of Vascular Surgery guidelines.

Following Institutional Ethics Committee approval (Approval No. 455/39, dated 07 May 2026), the follow-up period for study participants was extended from 2 years to 5 years. No other protocol changes were made.

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
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Extracranial carotid stenosis greater than 50% (NASCET) in the carotid bifurcation or internal carotid artery assessed by ultrasound in whom carotid revascularisation is planned;
  • The ability of the patient for follow-up examinations;
  • Personally signed informed consent

排除标准

  • Patients admitted due to emergency procedure for immediate surgical treatment (the same day);
  • Patients with preoperative anemia (due to any reason, hemoglobin level < 10 g/dL);
  • Patients in whom concomitant or "staged" cardiac surgery or vascular procedure is planned,
  • Patients who had an acute coronary event in the previous 3 months;
  • Patients undergoing multiple CEA/CAS during the study period;
  • Patients with end-stage kidney disease;
  • Patients with sepsis:
  • Patients with acute pericarditis/myocarditis;
  • Patients with advanced heart failure;
  • Patients on chemotherapy,
  • Patients with systemic inflammatory diseases;
  • Patients with critical limb ischemia;

结局指标

主要结局

The incidence of myocardial injury

时间窗: 2 days following surgery

Myocardial injury would be defined in accordance with the current Fourth Universal Definition of Myocardial Infarction, published by the European Society of Cardiology, as the existence of at least one elevated troponin value above the 99th percentile of the upper reference limit.

The rate of cardiac-related death

时间窗: 2 years following surgery

Cardiac-related death would be defined as any lethal outcome that resulted due to progression of heart disease.

The incidence of myocardial infarction

时间窗: 2 years following surgery

Myocardial infarction would be defined as the existence of an increase and/or decrease in troponin levels and clinical signs of acute myocardial ischemia, in accordance with the Fourth Universal Definition of Myocardial Infarction.

The incidence of stroke

时间窗: 2 years following surgery

Stroke would be defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin, with the evidence of acute infarction on brain computed tomography or magnetic resonance imaging.

The rate of all-cause mortality

时间窗: 2 years following surgery

All-cause mortality would refer to any lethal outcome (due to any cause), that would occur during the study.

The incidence of myocardial injury

时间窗: preoperatively

Myocardial injury would be defined in accordance with the current Fourth Universal Definition of Myocardial Infarction, published by the European Society of Cardiology, as the existence of at least one elevated troponin value above the 99th percentile of the upper reference limit.

The incidence of myocardial infarction

时间窗: 2nd postoperative day

Myocardial infarction would be defined as the existence of an increase and/or decrease in troponin levels and clinical signs of acute myocardial ischemia, in accordance with the Fourth Universal Definition of Myocardial Infarction.

The rate of cardiac-related death

时间窗: 2nd postoperative day

Cardiac-related death would be defined as any lethal outcome that resulted due to progression of heart disease.

The incidence of stroke

时间窗: 2nd postoperative day

Stroke would be defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin, with the evidence of acute infarction on brain computed tomography or magnetic resonance imaging.

The rate of all-cause mortality

时间窗: 2nd postoperative day

All-cause mortality would refer to any lethal outcome (due to any cause), that would occur during the study.

The incidence of myocardial infarction

时间窗: 5 years following surgery

Myocardial infarction would be defined as the existence of an increase and/or decrease in troponin levels and clinical signs of acute myocardial ischemia, in accordance with the Fourth Universal Definition of Myocardial Infarction.

The rate of cardiac-related death

时间窗: 5 years following surgery

Cardiac-related death would be defined as any lethal outcome that resulted due to progression of heart disease.

The incidence of stroke

时间窗: 5 years following surgery

Stroke would be defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin, with the evidence of acute infarction on brain computed tomography or magnetic resonance imaging.

The rate of all-cause mortality

时间窗: 5 years following surgery

All-cause mortality would refer to any lethal outcome (due to any cause), that would occur during the study.

次要结局

未报告次要终点

研究者

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

Igor Koncar

Vascular surgeon, MD, Ph.D.

University of Belgrade

研究点 (2)

Loading locations...

相似试验