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临床试验/NCT04699110
NCT04699110已完成4 期

Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome

National Institute of Cardiovascular Diseases, Pakistan1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
201
试验地点
1
主要终点
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade

研究概览

简要总结

No-reflow is defined as the lack of myocardial perfusion despite opening of the epicardial coronary vessels in the setting of percutaneous coronary intervention (PCI). It has been demonstrated that either impaired flow or the absence of flow is associated with an increased rate of mortality. Among available treatment options, intracoronary adenosine is widely used in clinical practice, moreover, adrenaline is a safe alternative for the cases where use of adenosine is limited due to presence of hypotension or bradycardia. Nonetheless, evidence from retrospective and observational studies suggest that intracoronary adrenaline is well tolerated and may exert encouraging effects in prompt recovery of flow in these patients. However, very limited data are available on efficacy of intracoronary (IC) adrenaline in normotensive patients. Therefore, this study is planned to study the hypothesis that; intracoronary adrenaline is safe and has significantly higher efficacy as compared to adenosine for the treatment of no-reflow in normotensive patients with acute coronary syndrome.

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
None

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

  • All patients with acute coronary syndrome who developed No-reflow during PCI.
  • Patients with systolic blood pressure of > 100 mmHg.

排除标准

  • Hypotensive patients
  • Patients with Valvular or congenital heart disease.
  • Patients with Atypical chest pain
  • Patients with Cardiomyopathy
  • Patients with Pericarditis
  • Patients with Myocarditis
  • Patients refused to give consent

研究组 & 干预措施

Control group

Active Comparator

Patients receiving intracoronary adenosine

干预措施: Adenosine (Drug)

Treatment group

Experimental

Patients receiving intracoronary adrenaline

干预措施: Adrenaline (Drug)

结局指标

主要结局

Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade

时间窗: Immediately after administration of drug

Reduction in TIMI frame count

时间窗: Immediately after administration of drug

次要结局

  • The major adverse cardiovascular events(During hospital stay and at 30-day follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kamran Ahmed Khan

Assistant Professor of Cardiology

National Institute of Cardiovascular Diseases, Pakistan

研究点 (1)

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