Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 28
- 主要终点
- Coronary TIMI frame count after balloon dilatation
研究概览
简要总结
Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following PPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during PPCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic symptoms < 12h, or evidence of ongoing ischemia 12h after symptom onset
- •Continued ischemic chest pain > 30min
- •ST-segment elevation ≥ 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB)
- •Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL)
- •Primary coronary artery angiography was planned.
排除标准
- •Emergency thrombolytic therapy was performed before primary coronary artery angiography
- •Cardiogenic shock with no response to hypervolemic treatment or vasopressor
- •Severe cardiomyopathy or valvular disease requiring intervention
- •Coronary ectasia
- •Severe heart failure
- •Contraindication or allergy to antiplatelet drugs
- •Contraindication or allergy to experimental drugs
- •Unable to receive at least 1 year of dual antiplatelet therapy
- •Active bleeding or extreme-risk for major bleeding
- •Severe liver or renal failure
- •Life expectancy < 1 year
- •Unable or unwilling to provide informed consent
- •Women of child bearing potential
- •Under 18 years of age
- •Hemoglobin < 90g/L
- •Platelet count < 100×10^9/L
- •Can not cooperate (with mental disorders or cognitive disorders)
研究组 & 干预措施
Nitroprusside group
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Nitroprusside Sodium via guide-catheter was performed. Then repeated administration of Nitroprusside Sodium was done prior to coronary stent implantation or post dilatation.
干预措施: Nitroprusside Sodium (Drug)
Tirofiban group
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Tirofiban Hydrochloride via guide-catheter was performed.
干预措施: Tirofiban Hydrochloride (Drug)
Control group
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of heparinized saline via guide-catheter was performed.
干预措施: Heparinized saline (Drug)
结局指标
主要结局
Coronary TIMI frame count after balloon dilatation
时间窗: 1 minute after balloon dilatation
A continuous measurement assessing flow in the epicardial arteries.
Coronary artery flow using TIMI flow grade after balloon dilatation
时间窗: 1 minute after balloon dilatation
Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.
Coronary TIMI frame count after stent implantation
时间窗: 1 minute after stent implantation
A continuous measurement assessing flow in the epicardial arteries.
Slow flow / no-reflow phenomenon after stent implantation
时间窗: 1 minute after stent implantation
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
Slow flow / no-reflow phenomenon after balloon dilatation
时间窗: 1 minute after balloon dilatation
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation
时间窗: 1 minute after stent implantation
Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.
ECG ST-segment fall more than 50%
时间窗: in 2 hours post-PCI
The extent of ST segment elevation was reduced by more than 50%
次要结局
- Main adverse cardiovascular and cerebrovascular events (MACCE)(at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI)
研究者
Chunguang Qiu
Director of the Department of Cardiovascular Medicine
The First Affiliated Hospital of Zhengzhou University