Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,148
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
Primary objective of the study is to evaluate the impact of adenosine pre-medication on incidence of slow flow/no-reflow after primary percutaneous coronary intervention.
详细描述
Background:
Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for ST-segment elevation myocardial infarction (STEMI); however, optimal myocardial perfusion is not achieved in all patients due to the slow flow/no-reflow phenomenon. This condition, defined as inadequate myocardial perfusion despite patent epicardial arteries, is associated with worse clinical outcomes. Adenosine, owing to its vasodilatory, anti-inflammatory, and antiplatelet properties, may improve microvascular perfusion. While its use during PCI is established, its prophylactic role prior to PCI remains unclear.
Study Design:
This is a multicenter, single-blinded, randomized controlled trial conducted at NICVD Karachi and its satellite centers (Liyari and Larkana) over 12 months. A total of 1,148 STEMI patients undergoing primary PCI will be randomized in a 1:1 ratio using block randomization.
Intervention:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with acute STEMI undergoing primary PCI
- •Patients of either sex, ≥18 years of age.
排除标准
- •STEMI patients with cardiogenic shock at presentation
- •Patients with heart block
- •Allergy to adenosine
- •Patients refuse to give consent for participation
研究组 & 干预措施
Intervention Group (Adenosine Pre-Medication + Standard Care)
Patients will receive intracoronary adenosine prior to primary PCI:
Dose: 2 mg for left coronary artery, 1 mg for right coronary artery Dilution: 20 mL normal saline Route: Intracoronary (proximal via guide or distal via device) Purpose: To reduce incidence of slow flow/no-reflow and improve myocardial perfusion.
Other Names: Adenocard (if needed for registry consistency)
干预措施: Adenosine pre-medication (Drug)
Intervention Group (Adenosine Pre-Medication + Standard Care)
Patients will receive intracoronary adenosine prior to primary PCI:
Dose: 2 mg for left coronary artery, 1 mg for right coronary artery Dilution: 20 mL normal saline Route: Intracoronary (proximal via guide or distal via device) Purpose: To reduce incidence of slow flow/no-reflow and improve myocardial perfusion.
Other Names: Adenocard (if needed for registry consistency)
干预措施: Standard care (Other)
Control Group (Standard Care Alone)
Patients will undergo primary PCI with standard pharmacological therapy, without adenosine pre-medication.
Purpose: Serve as comparator to evaluate the effect of adenosine pre-medication.
干预措施: Standard care (Other)
结局指标
主要结局
Primary Outcome
时间窗: During Procedure
Slow flow/no-reflow: will be categorized as final TIMI 0 to II flow
次要结局
未报告次要终点
研究者
Dr. Muhammad Nauman Khan
Associate Professor
National Institute of Cardiovascular Diseases, Pakistan