跳至主要内容
临床试验/NCT05965375
NCT05965375尚未招募不适用

Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias (FUTURE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2024年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
5,000
试验地点
1
主要终点
Change in the incidence of MACCE

研究概览

简要总结

The investigation of biomarkers for immune status and metabolic state, as well as host microbiota composition, in patients with ventricular arrhythmias before and after radiofrequency ablation, can provide new insights for specific and personalized treatment. This can help establish early prediction and prognosis models and provide a basis for clinically effective diagnosis and treatment.

详细描述

Abnormal immune and metabolic states can lead to the occurrence of various systemic diseases, including the development of cardiovascular diseases through multiple mechanisms. On the other hand, various diseases can also feedback and regulate the immune and metabolic systems. However, currently there is no research on the impact of immune and metabolic states on ventricular arrhythmia. Exploring the biomarker characteristics and risk stratification of patients with ventricular arrhythmias undergoing radiofrequency ablation before and after the procedure can provide new insights for specific and personalized treatment. It can establish early prediction and prognostic models, providing evidence for clinically effective diagnosis and treatment.

研究设计

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

入排标准

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

入选标准

  • Patients with ventricular premature beats, ventricular tachycardia, or ventricular fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.

排除标准

  • Age <18 or >80 years old;
  • Patients with autoimmune diseases or immune deficiencies, or those who have used immunosuppressive or immune modulating agents in the past 3 months;
  • Platelet count <100×10^9/L or functional platelet defects;
  • Congenital or acquired coagulation or bleeding disorders;
  • Patients with a history of organ transplantation or are preparing to receive organ transplantation;
  • Unwilling to sign an informed consent or cooperate with the examination.

结局指标

主要结局

Change in the incidence of MACCE

时间窗: 3,6 months,1,3,5 years after enrollment.

Major adverse cardiovascular and cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.

次要结局

  • Change in the incidence of vessel revascularization(3,6 months,1,3,5 years after enrollment.)
  • Change in the incidence of all-cause death(3,6 months,1,3,5 years after enrollment.)
  • Change in the incidence of myocardial infarction(3,6 months,1,3,5 years after enrollment.)
  • Change in the incidence of stroke(3,6 months,1,3,5 years after enrollment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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