Ignite Creation Date:
2024-05-06 @ 1:24 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01797484
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2013-02-20
Brief Title:
Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIMINI-Pilot
Brief 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 ie area of ischemic myocardium is directly related to the rate of complications ie left-ventricular pump failure malignant arrhythmia and the grade of Rehabilitation to daily life ie 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 ie 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 ischemia56 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 RanolazinePlacebo will be done after conclusion of the RIMINI-Trial to show the effect of Ranolazine 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 ie area of ischemic myocardium is directly related to the rate of complications ie left-ventricular pump failure malignant arrhythmia and the grade of Rehabilitation to daily life ie 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 ie 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 ischemia56 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 RanolazinePlacebo will be done after conclusion of the RIMINI-Trial to show the effect of Ranolazine in acute myocardial ischemia
Detailed Description:
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 ie area of ischemic myocardium is directly related to
1 Rate of complications ie left-ventricular pump failure malignant arrhythmia
2 Grade of Rehabilitation to daily life ie 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
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 ie 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 Serum levels of Troponin-T-hs 14 pgml proof of myocardial dyskinesia and angina pectoris CCS II Canadian Cardiovascular Society Classification of Angina Pectoris in the patient history will receive unaltered guideline-based therapy for acute cardiac ischemia56 All necessary procedures will be performed to stabilize patients to a hemodynamically compensated state normalized levels of blood pressure heart rate absent malignant arrhythmia dyspnoea and angina-like symptoms and patients are then transferred to receive cardiac catheterization angiography and angioplasty if necessary
After patients are stabilized ie via angioplasty medical treatment Ranolazine will be given additionally to guideline-based medication Beta-Blocker ACE-Inhibitor or AT1-Inhibitor ASS Clopidogrel Statins
The measurement of the ischemic myocardial area will be done via three functional echocardiographies with speckle tracking technique10 speckle -tracking echocardiography SPE
1 The first speckle tracking for screening and will be done directly with patients presenting in the emergency room
2 After stabilization and coronary angiography or -plasty and before the first dose of Ranolazine is given the second speckle tracking will be done for baseline
3 After 42 days of Ranolazine-treatment the third and final speckle tracking echocardiography will be done
A statistical evaluation of ischemic myocardial area before and after treatment with RanolazinePlacebo will be done after conclusion of the RIMINI-Trial to show the effect of Ranolazine in acute myocardial ischemia
For controlling and comparing the effect the RIMINI-Trial will be single-blinded and compared to a group of patients not treated with Ranolazine Participants will be randomized to the treatment-group or the no-treatment-group using a computer based randomization-method
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 ie area of ischemic myocardium is directly related to
1 Rate of complications ie left-ventricular pump failure malignant arrhythmia
2 Grade of Rehabilitation to daily life ie 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
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 ie 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 Serum levels of Troponin-T-hs 14 pgml proof of myocardial dyskinesia and angina pectoris CCS II Canadian Cardiovascular Society Classification of Angina Pectoris in the patient history will receive unaltered guideline-based therapy for acute cardiac ischemia56 All necessary procedures will be performed to stabilize patients to a hemodynamically compensated state normalized levels of blood pressure heart rate absent malignant arrhythmia dyspnoea and angina-like symptoms and patients are then transferred to receive cardiac catheterization angiography and angioplasty if necessary
After patients are stabilized ie via angioplasty medical treatment Ranolazine will be given additionally to guideline-based medication Beta-Blocker ACE-Inhibitor or AT1-Inhibitor ASS Clopidogrel Statins
The measurement of the ischemic myocardial area will be done via three functional echocardiographies with speckle tracking technique10 speckle -tracking echocardiography SPE
1 The first speckle tracking for screening and will be done directly with patients presenting in the emergency room
2 After stabilization and coronary angiography or -plasty and before the first dose of Ranolazine is given the second speckle tracking will be done for baseline
3 After 42 days of Ranolazine-treatment the third and final speckle tracking echocardiography will be done
A statistical evaluation of ischemic myocardial area before and after treatment with RanolazinePlacebo will be done after conclusion of the RIMINI-Trial to show the effect of Ranolazine in acute myocardial ischemia
For controlling and comparing the effect the RIMINI-Trial will be single-blinded and compared to a group of patients not treated with Ranolazine Participants will be randomized to the treatment-group or the no-treatment-group using a computer based randomization-method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None