Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
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.