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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo is given as a Bolus (instead of Bolus application of Levosimendan) over 10 min i.v., starting 10 min before recanalization. |
|
| Bolus Levosimendan | Active Comparator | Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization. |
|
| Bolus and infusion Levosimendan | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan | Drug | In a prospective randomized setting, patients are included with an acute STEMI of the anterior wall. A bolus administration Levosimendan with/without following continuous infusion over 24 hours compared to a control group (placebo) will be examined. The initiation of therapy is carried out for 10 min. prior to reperfusion. The coronary Intervention is performed immediately after inclusion at the latest within 6 hours after the onset of symptoms. The administration of Levosimendan is based on a fixed schema: Bolus: 12 µg/kg over 10 min I. V., starting 10 min before recanalization and an addition of 0.1-0.2 µg/kg/min i. v. for 24 hours in the continuous infusion group. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the increase in left ventricular end-diastolic volume index (LVEDVi) | echocardiography and MRI examinations (LVEDVi) and comparison between baseline and 12 months data | 12 months after coronary intervention due to the infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the acute myocardial damage due to the infarction | MRI examination (infarction area) and comparison between baseline and 12 months data | 12 months after coronary intervention due to the infarction |
| Event-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Becker | Cardiology, RWTH University Hospital Aachen | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26965540 | Background | Brooks GC, Lee BK, Rao R, Lin F, Morin DP, Zweibel SL, Buxton AE, Pletcher MJ, Vittinghoff E, Olgin JE; PREDICTS Investigators. Predicting Persistent Left Ventricular Dysfunction Following Myocardial Infarction: The PREDICTS Study. J Am Coll Cardiol. 2016 Mar 15;67(10):1186-1196. doi: 10.1016/j.jacc.2015.12.042. | |
| 11748117 | Result |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
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|
collection of data from the patient after 12 months about adverse events as myocardial infarction, stroke, revascularization and death
| 12 months after coronary intervention due to the infarction |
| functional changes (imaging) | echocardiography and MRI examinations about LV function | 12 months after coronary intervention due to the infarction |
| structural changes | MRI examinations about fibrosis | 12 months after coronary intervention due to the infarction |
| functional changes (spirometry) | changes of capacity by spirometry. | 12 months after coronary intervention due to the infarction |
| Kloner RA, Jennings RB. Consequences of brief ischemia: stunning, preconditioning, and their clinical implications: part 2. Circulation. 2001 Dec 18;104(25):3158-67. doi: 10.1161/hc5001.100039. |
| 17855673 | Result | Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available. |
| 18359896 | Result | du Toit EF, Smith W, Muller C, Strijdom H, Stouthammer B, Woodiwiss AJ, Norton GR, Lochner A. Myocardial susceptibility to ischemic-reperfusion injury in a prediabetic model of dietary-induced obesity. Am J Physiol Heart Circ Physiol. 2008 May;294(5):H2336-43. doi: 10.1152/ajpheart.00481.2007. Epub 2008 Mar 21. |
| 19426242 | Result | Hein M, Roehl AB, Baumert JH, Scherer K, Steendijk P, Rossaint R. Anti-ischemic effects of inotropic agents in experimental right ventricular infarction. Acta Anaesthesiol Scand. 2009 Aug;53(7):941-8. doi: 10.1111/j.1399-6576.2009.01994.x. Epub 2009 May 6. |
| 15023554 | Result | Kin H, Zhao ZQ, Sun HY, Wang NP, Corvera JS, Halkos ME, Kerendi F, Guyton RA, Vinten-Johansen J. Postconditioning attenuates myocardial ischemia-reperfusion injury by inhibiting events in the early minutes of reperfusion. Cardiovasc Res. 2004 Apr 1;62(1):74-85. doi: 10.1016/j.cardiores.2004.01.006. |
| 23063476 | Result | Qarawani D, Cohen A, Nahir M, Hasin Y. Facilitation of left ventricular function recovery post percutaneous coronary intervention by levosimendan. Int J Cardiol. 2013 Sep 20;168(1):237-42. doi: 10.1016/j.ijcard.2012.09.088. Epub 2012 Oct 11. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |