Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction An Open-label, Single Center Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- The resolution of myocardial stunning at 48 hours (StunningRes48h).
研究概览
简要总结
The aim of this study is to evaluate the effect of adenosine on the recovery of myocardial akinesia in ST-elevation myocardial infarction (STEMI). The study is a single-center randomized clinical trial intending to include 90 patients.
The objective of the study is to investigate whether treatment with adenosine hastens recovery of myocardial akinesia and improves cardiac function at 48 hours in patients with STEMI.
详细描述
Primary endpoint (variable):
The resolution of myocardial stunning at 48 hours (StunningRes48h).
The proportion of stunning that has resolved at 48 hours will be calculated according to the formula:
StunningRes48h = (%AkinesiaBaseline - %Akinesia48h) / (%AkinesiaBaseline - %Akinesia30days) where %AkinesiaT is defined as the endocardial length of the akinetic myocardium measured in end-diastole divided by the total endocardial length measured in end-diastole in the 2- and 4-chamber view, at time T (T= 48h or 30 days)
Secondary endpoint(s) (variables):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Age >18 years.
- •Anterior STEMI.
- •Symptom duration ≤6 hours
- •Written informed consent obtained - Angiographic Inclusion criteria:
- •Culprit lesion in LAD, major branch of LAD, proximal or mid LCx or proximal or mid RCA
- •TIMI flow ≤2 in the culprit vessel
- •Echocardiographic inclusion criteria:
- •Detectable hypo- or akinesia corresponding to ≥5% of the left ventricle corresponding to culprit lesion, per bedside visual assessment.
排除标准
- •Previous randomization in the study
- •Any of the following contraindications for treatment with adenosine:
- •Known pre-existing atrioventricular block grade ≥2 or sick sinus syndrome in patients without pacemaker.
- •Known pre-existing elevation of intracranial pressure
- •Treatment with dipyridamole within 24 hours of randomization
- •Systolic blood pressure <80 mm Hg at screening
- •Any concomitant condition resulting in a life expectancy of less than one month
- •Previous myocardial infarction or other cardiac condition resulting in impaired regional or global systolic function without documented recovery of cardiac function
- •Heart transplant or left ventricular assist device recipient
- •Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis or characteristics that may interfere with adherence to the trial protocol
- •Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception -
研究组 & 干预措施
Adenosine
Adenosine infusion 70 µg/kg/min initiated prior to revascularization and maintained for 6 hours
干预措施: Adenosine (Drug)
结局指标
主要结局
The resolution of myocardial stunning at 48 hours (StunningRes48h).
时间窗: 48 hours
The proportion of stunning that has resolved at 48 hours will be calculated according to the formula: StunningRes48h = (%AkinesiaBaseline - %Akinesia48h) / (%AkinesiaBaseline - %Akinesia30days) where %AkinesiaT is defined as the endocardial length of the akinetic myocardium measured in end-diastole divided by the total endocardial length measured in end-diastole in the 2- and 4-chamber view, at time T (T= 48h or 30 days)
次要结局
- Mortality(6 months)
- Sustained ventricular tachycardia or fibrillation(72 hours)
- Cardiac assist device(72 hours)
- Worsening heart failure(≥12 hours)
- Infarct size(6 months)
- High-grade atrioventricular block or sinus arrest(72 hours)
- Composite(≥12 hours or 6 months)
- Stroke(6 months)
- Ejection fraction(Day 1, Day 2, Day 3, Day 7, Day 14, Day 30 and 6 months)
- Rehospitalization(6 months)