Clinical trial NCT03022877: Acute and Chronic Protective Effects of Peri-interventional Administration of Levosimendan in ST Elevation Myocardial Infarctions
Official title: Acute and Chronic Protective Effects of Peri-interventional Administration of Levosimendan in ST Elevation Myocardial Infarctions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myocardial Infarction
Outcome
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* STEMI of the anterior wall \< 6 hrs
* capacity to Consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reduction of the increase in left ventricular end-diastolic volume index (LVEDVi)
timeFrame: 12 months after coronary intervention due to the infarction
Secondary outcomes:
measure: Size of the acute myocardial damage due to the infarction
timeFrame: 12 months after coronary intervention due to the infarction
measure: Event-free survival
timeFrame: 12 months after coronary intervention due to the infarction
measure: functional changes (imaging)
timeFrame: 12 months after coronary intervention due to the infarction
measure: structural changes
timeFrame: 12 months after coronary intervention due to the infarction
measure: functional changes (spirometry)
timeFrame: 12 months after coronary intervention due to the infarction
Other outcomes:
Locations:
Study officials:
affiliation: Cardiology, RWTH University Hospital Aachen
name: Michael Becker
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.