Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ratio of myocardial infarct size to area at risk assessed by MRI
研究概览
简要总结
In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) >30.
详细描述
After coronary stenting, index of microvascular resistance (IMR) will be measured invasively. Patients with IMR >30 will be randomised to 20 mg alteplase or placebo (NaCl) administered in the culprit vessel through a microcatheter. Magnet resonance imaging (MRI) of the myocardium will be performed early (2-6 days) and late (3 months) to estimate the primary endpoint (infarct size).
10 non-randomised patients, with IMR <30, will undergo the same follow-up as the randomised patients.
Clinical events for all randomised and non-randomised patients will be collected from Swedish national registries and by telephone at 3 and 12 months.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral and signed informed consent
- •Males and females 18 - 85 years of age
- •Diagnosis of ST-elevation myocardial infarction (STEMI) including occlusion of culprit vessel on angiography
- •Onset of continuous symptoms within 12 hours
- •Have undergone PCI of culprit vessel
- •Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent
排除标准
- •Previously known ejection fraction <30%
- •Previous PCI in the culprit vessel
- •Chronic total occlusion in major vessel
- •Any history of bleeding diathesis, known coagulopathy, or will refuse blood transfusions
- •Recent history or known platelet count <100.000 cells/mm3 or Hbg < 10 g/dL
- •Known reduced kidney function with estimated glomerular filtration rate (GFR) <30 ml/min/1.73m
- •Previous hemorrhagic stroke
- •Ongoing oral anticoagulation treatment
- •Severe asthma requiring daily treatment
- •Any mechanical complication (e.g. ventricular septal defect, papillary muscle rupture, cardiac tamponade)
- •Atrioventricular block grade III
- •Known inability to undergo MRI investigation
- •Permanent pacemaker
- •Pronounced claustrophobia
- •Known intolerance to study drug
- •Known intolerance to adenosine
- •Participation in another investigational drug study
- •Previous randomization in the OPTIMAL-PCI trial
研究组 & 干预措施
Alteplase
40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel
干预措施: alteplase (Drug)
Placebo
40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel
干预措施: Placebo (Drug)
结局指标
主要结局
Ratio of myocardial infarct size to area at risk assessed by MRI
时间窗: 3 months
MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size
次要结局
- Change in hemoglobin(12 hours)
- Level of NtProBNP(12 hours)
- Non invasive CFR(3 months)
- Peak level of Troponin T(12 hours)
- Change of index of microvascular resistance and coronary flow reserve(Immediately after drug administration during invasive index procedure)
- Degree of microvascular obstruction assessed by MRI(2-6 days)
- Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)(12 months)
- Re-hospitalisation for heart failure(12 months)
- Re-hospitalisation for myocardial infarction(12 months)
- Cardiovascular death(12 months)
- Bleeding according to BARC-criteria(7 days)
- Myocardial hemorrhage at MRI(2-6 days)