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临床试验/NCT03488407
NCT03488407已完成不适用

A Prospective Study to Evaluate Feasibility of Routine Use of Radial Access for Primary Angioplasty and to Assess it in Subgroups With Unfavorable Characteristics

Jubilee Mission Medical College and Research Institute0 个研究点目标入组 315 人开始时间: 2016年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
315
主要终点
Evaluation of radial angioplasty success in whole cohort.

研究概览

简要总结

Primary percutaneous coronary intervention is the preferred treatment for patients with ST-segment acute coronary syndrome. The radial access is an established approach, associated with a reduction in vascular access related complications after primary percutaneous coronary interventions. The purpose of this study is to examine the baseline characteristics, risk factors, procedural parameters and complications in patients with STEMI taken for primary angioplasty by radial access.

Data of all patients with acute STEMI with primary PCI through radial access is to be evaluated for baseline characteristics and procedural parameters and complications. Patients in the prospective study are followed up till discharge and any in-hospital complication noted.

This was a prospective, observational and descriptive study. Three hundred fifteen consecutive patients with an ST-segment elevation acute myocardial infarction (STEMI) treated with primary angioplasty by radial access, admitted between March 2016 and Feb 2017 were analyzed for their baseline characteristics, risk factors, and procedural parameters, complications and outcomes. High risk sub-groups analysis was also done. High risk groups includes patients with age >75yrs, cardiogenic shock, severe LV systolic dysfunction, acute left ventricular failure, high degree AV block, right ventricular infarction and low BMI. The study is conducted among patients with acute STEMI, considered for primary PCI through radial artery access at operator discretion.

This study analyzed the baseline characteristics of patients which includes clinical history, clinical examination, ECG, 2D ECHO, coronary angiogram to evaluate cardiovascular risk factors.

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

  • All patients presenting with STEMI and being considered for primary PCI through radial access between March 2016 and Feb 2017.

排除标准

  • Patients with ACS other than STEMI
  • All primary PCI in STEMI through femoral access.
  • All radial elective PCI.

结局指标

主要结局

Evaluation of radial angioplasty success in whole cohort.

时间窗: one year

Angioplasty success rate (by TIMI flow grade)

Evaluation of in-hospital complication.

时间窗: One year

Rate of local complications

次要结局

  • High risk v/s non-high risk subgroup analysis(one year)

研究者

发起方
Jubilee Mission Medical College and Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Rajesh Sharma

Senior Resident

Jubilee Mission Medical College and Research Institute

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