Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Left Ventricular Global Strain Rate
研究概览
简要总结
The aim of the RIMINI-Trial is to examine the effect of Ranolazine on ischemic myocardium in acute myocardial ischemia.
A pilot-trial by Venkatamaran et al. recently demonstrated, that the area of ischemic myocardium in patients with stable coronary artery disease can be reduced by Ranolazine-treatment2. This effect was shown by significantly reduced areas of atypical or dysfunctional myocardium in SPECT-examinations.
The dimension of myocardial damage (i.e. area of ischemic myocardium) is directly related to the rate of complications (i.e. left-ventricular pump failure, malignant arrhythmia) and the grade of Rehabilitation to daily life (i.e. persistent reduced left-ventricular ejection fraction).
In patients with stable angina pectoris, Ranolazine is used with beneficial results1. Ranolazine improves diastolic blood flow and therefore microcirculation in the myocardium by reducing diastolic tension (via inhibiting late Na+-Influx and consecutive Ca2+-Overload).
Recently published data2 showed that treatment with Ranolazine significantly reduces the ischemic area in chronic damaged myocardium. This is due the effect of improved microcirculation in hibernating myocardium.
Early administration of Ranolazine and improvement of microcirculation in patients with acute damaged myocardium (i.e. directly after acute ischemia) should lead to a recruitment and re-uptake of cardiac activity of hibernating myocardium.
For the RIMINI-Trial patients are given Ranolazine on top of the guideline-based treatment to reduce the area of acute ischemic myocardium.
Patients with unstable angina pectoris and proof of acute cardiac ischemia, proof of myocardial dyskinesia and angina pectoris in the patient history will receive unaltered guideline-based therapy for acute cardiac ischemia5,6. All necessary procedures will be performed to stabilize patients to a hemodynamically compensated state and patients are then transferred to receive cardiac catheterization (angiography and angioplasty if necessary).
After patients are stabilized Ranolazine will be given additionally to guideline based medication.
The measurement of the ischemic myocardial area will be done via three functional echocardiographies with speckle tracking technique10.
A statistical evaluation of ischemic myocardial area before and after treatment with Ranolazine/Placebo will be done after conclusion of the RIMINI-Trial to show the effect of Ranolazine in acute myocardial ischemia.
详细描述
The aim of the RIMINI-Trial is to examine the effect of Ranolazine on ischemic myocardium in acute myocardial ischemia.
A pilot-trial by Venkatamaran et al. recently demonstrated, that the area of ischemic myocardium in patients with stable coronary artery disease can be reduced by Ranolazine-treatment2. This effect was shown by significantly reduced areas of atypical or dysfunctional myocardium in SPECT-examinations.
The dimension of myocardial damage (i.e. area of ischemic myocardium) is directly related to:
- Rate of complications (i.e. left-ventricular pump failure, malignant arrhythmia)
- Grade of Rehabilitation to daily life (i.e. persistent reduced left-ventricular ejection fraction)
Early angioplasty and coronary medication are key factors for preventing complications and ensuring sufficient rehabilitation. This is done to reduce the ischemic area as best as possible.
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
- 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
- •Proof of acute cardiac ischemia by elevated serum Troponin T-hs levels > 14 pg/nl
- •Proof of myocardial dyskinesia with functional echocardiography ("speckle tracking")
- •Stable angina pectoris >/= CCS II in patient history
- •Stabilized (i.e. normalized vital parameters) patients after coronary angioplasty or angiography
- •Coronary angioplasty or angiography not older than 24 hours
- •Written informed consent
- •Established standard therapy for coronary artery disease (i.e. Beta-Blocker, ACE-Inhibitor or AT1-Inhibitor, ASS, Clopidogrel, Statins)
排除标准
- •Patients younger than 18 years of age
- •Acute cardio-pulmonary decompensation
- •Middle and high grade liver insufficiency (Child-Pugh Score B and C)
- •High grade renal insufficiency (Creatinine-Clearance < 30 ml/min)
- •Concomitant treatment with potent inhibitors of CYP3A4
- •Concomitant administration of class Ia (e.g. quinidine) or class III (e.g. dofetilide, sotalol) antiarrhythmics, except for amiodarone
- •Concomitant administration of > 20 mg simvastatin/day
- •Patients with heart failure classification NYHA III and NYHA IV
- •Homeless patients and drug-addicted patients
- •Pregnant and/or breast-feeding women
- •Treatment with Ranolazine prior to enrolment in RIMINI-Trial
- •Allergy against Ranolazine
研究组 & 干预措施
Ranolazine
Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days
干预措施: Ranolazine (Drug)
结局指标
主要结局
Left Ventricular Global Strain Rate
时间窗: 42 days after first dose of Ranolazine
Relativ acceleration or deceleration (1/s) of left ventricular myocardial sections compared to direct opposite section. The more positive the value, the more simultaneously the movements, the more hemodynamically better.
次要结局
未报告次要终点
研究者
Tjark Frederik Schwemer
Dr. med.
Universitätsklinikum Hamburg-Eppendorf