Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia (RIMINI-Pilot)
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.
|Coronary Artery Disease Acute Myocardial Ischemia||Drug: Ranolazine||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia|
- Area of ischemic myocardium/cm² (longitudinal strain, radial/circumferential strain) [ Time Frame: 42 days after first dose of Ranolazine ]
- Incidence of cardiac complications (i.e. ventricular tachycardia, re-infarction, rehospitalisation for revascularization) [ Time Frame: 42 days after first dose of Ranolazine ]
- Level of cardiac markers (NT-pro-BNP, Troponin, CK, Copeptin) [ Time Frame: Before and 42 days after first dose of Ranolazine ]
|Study Start Date:||July 2013|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Ranolazine
Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days
Improvement of myocardial microcirculation
Other Name: Ranexa
No Intervention: No additional medication
No additional medication - control group
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01797484
|University Heart Center Hamburg Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Stefan Blankenberg, Prof. Dr.||Director of University Heart Center Hamburg Eppendorf|