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临床试验/NCT05510661
NCT05510661招募中不适用

Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export

National Institute of Cardiovascular Diseases, Pakistan2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Slow/No-reflow

研究概览

简要总结

Aim of this single center randomized open label trial with blinded in-hospital outcomes assessment is designed with aim to compare manual thrombus aspiration followed by percutaneous coronary intervention (PCI) strategy with PCI alone.

详细描述

Clinical benefit of manual aspiration has been a contentious point of debate and it is Class III indication in current clinical practice guidelines, however, recent observational data by Kumar D et al. showed benefits of usage of export in terms of favorable in-hospital outcomes and lesser complication rate in patients with total occlusion, furthermore, benefits of usage of export was observed to be directly associated with duration of chest pain at the time of thrombus aspiration. However, these observations are limited to immediate and in-hospital outcomes and data regarding efficacy of manual thrombus aspiration are not available.

Hence this single center randomized open label trial is designed with specific aim to test the following hypothesis for STEMI patients with total occlusion undergoing primary PCI;

  • Whether use of export catheter reduces in-hospital and short term adverse events
  • Whether use of export reduces slow flow or no reflow
  • Whether use of export reduces the use of intracoronary drugs
  • Whether use of export within 6 hours of symptom onset significantly reduces in-hospital and short term adverse events

Consecutively recruited patients will be randomized to either primary PCI with export or primary PCI alone group in 2:1 ratio. Post aspiration immediate TIMI flow will be observed and all the patients will be observed for adverse outcomes (MACE) and complications including slow flow/no-reflow. Follow-up intervals will be at the end of one month of randomization and end of 6 month of randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Blinded in-hospital outcomes assessment will be insured by separating patients recruitment and follow-up team and follow-up team will be kept blinded of randomization. All the patients will be assigned a unique identity code and collected data will be stored against the assigned code.

入排标准

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

入选标准

  • Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes
  • Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
  • Chest pain < 12 hours duration
  • Total occlusion (TIMI 0 flow)
  • Patients undergoing primary PCI
  • Informed consent

排除标准

  • Patients with prior history of cardiac related surgery or intervention
  • Performance of a rescue PCI after thrombolysis
  • Known existence of a disease resulting in a life expectancy of less than 6 months
  • Killip class III, IV

研究组 & 干预措施

Intervention Group

Experimental

Manual thrombus aspiration (use of export catheter) followed by primary PCI

干预措施: Export Catheter (Device)

Control group

Active Comparator

Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI

干预措施: Balloon catheter (Device)

结局指标

主要结局

Slow/No-reflow

时间窗: Immediately after procedure

TIMI 0-II flow

Post thrombus aspiration TIMI flow

时间窗: Immediately after export/balloon

Immediate TIMI flow after export/balloon

Major adverse cardiac events

时间窗: In-hospital, at 1 month, and at 6 months

It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis

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

Faiza Farooq

Acting Associate Professor

National Institute of Cardiovascular Diseases, Pakistan

研究点 (2)

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