Acute and Chronic Protective Effects of Peri-interventional Administration of Levosimendan in ST Elevation Myocardial Infarctions
- Registration Number
- NCT03022877
- Lead Sponsor
- RWTH Aachen University
- Brief Summary
In the proposed project the investigators want to assess whether the approach of the post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.
- Detailed Description
An acute ST-elevation myocardial infarction (STEMI) is a severe disease that triggers an adverse remodeling, and served in progressive heart failure with a case fatality rate of 50% in 5 years. The opening of the occluded vessel is the first and most important therapy, the reperfusion improved both the function as well as the long-term survival. At the same time, experimental and clinical studies show, however, that this reperfusion self-reinforced damage of the myocardium. An additional Intervention in this trigger phase could not only reduce the acute damage, but long-term protective effects. Both effects could be an approach for the Calcium-Sensitizer Levosimendan in the animal model. So far, no clear effect on the remodeling and survive was demonstrated after myocardial infarction in the clinic. This could be mainly due to the delayed application in relation to the reperfusion and on the selection of suitable methods for the presentation of the effects on myocardial structure and function. In the proposed project the investigators want to assess whether the approach of the post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- STEMI of the anterior wall < 6 hrs
- capacity to Consent
- previous myocardial infarction or bypass surgery
- relevant vitium
- STEMI of the posterior wall
- any contraindications to MRI
- unstable hemodynamics (hypotension, catecholamine therapy, severe arrhythmia), -respiratory failure
- onset of symptoms more than 6 hours.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bolus Levosimendan Levosimendan Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization. Placebo Levosimendan Placebo is given as a Bolus (instead of Bolus application of Levosimendan) over 10 min i.v., starting 10 min before recanalization. Bolus and infusion Levosimendan Levosimendan Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization and additionally as continuous infusion (0.1-0.2 µg/kg/min i. v. for 24 hours).
- Primary Outcome Measures
Name Time Method Reduction of the increase in left ventricular end-diastolic volume index (LVEDVi) 12 months after coronary intervention due to the infarction echocardiography and MRI examinations (LVEDVi) and comparison between baseline and 12 months data
- Secondary Outcome Measures
Name Time Method structural changes 12 months after coronary intervention due to the infarction MRI examinations about fibrosis
functional changes (spirometry) 12 months after coronary intervention due to the infarction changes of capacity by spirometry.
Event-free survival 12 months after coronary intervention due to the infarction collection of data from the patient after 12 months about adverse events as myocardial infarction, stroke, revascularization and death
Size of the acute myocardial damage due to the infarction 12 months after coronary intervention due to the infarction MRI examination (infarction area) and comparison between baseline and 12 months data
functional changes (imaging) 12 months after coronary intervention due to the infarction echocardiography and MRI examinations about LV function