跳至主要内容
临床试验/CTRI/2024/02/062809
CTRI/2024/02/062809招募中不适用

A Prospective Multicenter Indian LMCA Registry

Interventional Cardiology Research And Training Foundation49 个研究点 分布在 1 个国家目标入组 7,500 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
7,500
试验地点
49
主要终点
1. Procedural success

研究概览

简要总结

The left main coronary artery is distinguished by its larger diameter, broad distal bifurcation angle and the perfusion of a significant portion of the myocardium. The disease of LMCA are associated with the highest risk of morbidity and mortality among the subsets of coronary artery diseases with 70% damage to the myocardium when compared with other obstructive CADs.

Coronary artery bypass grafting (CABG) has traditionally been the gold standard for the management of patients with LMCA. However, percutaneous coronary intervention (PCI) has emerged as an alternative to CABG owing to its low periprocedural risk and continuous advancement in technology to provide better long-term outcomes and prognosis. Various systematic reviews and meta-analyses have documented clinical outcomes and long-term mortality among patients undergoing LMCA revascularization with CABG and PCI techniques. The drug-eluting stents have been a breakthrough in the PCI of LMCA and literature provides evidence on the safety and efficacy of using these stents in LMCA stenosis

There is a dearth of research on the clinical outcome of PCI for treating lesions in LMCA in India. Considering this, the data for the registry will be collected to assess the clinical outcomes of PCI with DES in patients with lesions in LMCA. This registry will be a prospective, multicentre, observational data collection study involving patients requiring PCI in LMCA.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender aged ≥18years, with a diagnosis of stable ischemic heart disease (SIHD) or acute coronary syndrome (ACS)
  • PCI with single or multiple DES for the treatment of lesion located at LMCA and defined as diameter stenosis ≥50% by visual estimation
  • Patients willing to sign the informed consent form.

排除标准

  • Patients who have a life expectancy of less than 12 months
  • Contraindication for dual antiplatelet therapy(DAPT).

结局指标

主要结局

1. Procedural success

时间窗: 1. In-hospital | 2. 12 Months

2. Rate of MACE

时间窗: 1. In-hospital | 2. 12 Months

次要结局

  • Rate of individual MACE - cardiac death, MI, TLR, TVR(12 Months)

研究者

发起方
Interventional Cardiology Research And Training Foundation
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Prathap Kumar N

Interventional Cardiology Research and Training Foundation

研究点 (49)

Loading locations...

相似试验