跳至主要内容
临床试验/NCT05411445
NCT05411445招募中不适用

Study of Role of Blood Microvescicles and Exosomes in Patients With Graft Occlusion After Aortocoronary Bypass Surgery

Maria Cecilia Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年6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
300
试验地点
1
主要终点
Confirmation and validation of the potential role of blood MV and exosomes as predictors of bypass occlusions

研究概览

简要总结

Coronary artery bypass graft (CABG) surgery is still the standard treatment of coronary revascularization for patients with severe coronary artery disease (CAD). Graft patency, together with completeness of revascularization, is a major determinant of long-term outcome following CABG. The surgical procedure elicits a persistent systemic inflammatory response associated with the activation of the hemostatic system leading to perturbation of endothelial and vascular function and activation of platelets and leukocytes. All of these events are the main players responsible for the early and late graft failure in a significant percentage of patients.

详细描述

Circulating microvesicles (MVs) have received increasing attention during the last years as novel players in cardiovascular disease. MVs are small membrane vesicles involved in cell-to-cell communication acting as biological messengers. MVs of different origin are present in the circulation of healthy subjects, and their number increases in several pathological conditions contributing to the development, progression, and clinical outcome of diseases. They have been proposed as biomarkers of thrombosis, vascular injury, and inflammation in atherothrombosis and myocardial infarction, where elevated levels have been correlated with disease severity. Among the circulating MVs, those expressing phosphatidylserine are defined as procoagulant MVs. A subgroup of procoagulant MVs also express tissue factor (TF), the key activator of the blood coagulation cascade. These procoagulant MVs have a role in the prediction of cardiovascular events and are able to identify patients at high recurrence risk. Thus far, many studies have generated compelling data on the sensitivity of circulating MVs as biomarkers of cardiovascular disease progression and events. The usefulness of MVs in patients undergoing CABG, however, has only been tested in 1 study that highlighted their importance in surgical hemostasis. No information is so far available on the association between the amount or pattern of circulating MVs and CABG outcome.Thus, we carried out this study to investigate potential functional role of MVs and exosomes in graft occlusion based on their protein profile as well as their procoagulant potentia.l

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between the ages of 40 and 80
  • Ejection fraction> 30%
  • coronary artery bypass surgery
  • informed consent
  • Willingness to carry out the follow-up visits and the assessments required by the protocol

排除标准

  • emergency intervention
  • changes in liver or kidney function
  • changes in coagulation factors
  • associated interventions (valve replacement, carotid endarterectomy)

结局指标

主要结局

Confirmation and validation of the potential role of blood MV and exosomes as predictors of bypass occlusions

时间窗: from 15 to 21 months

次要结局

未报告次要终点

研究者

发起方
Maria Cecilia Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验