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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03022877
Other study ID # Levo-STEMI
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2017
Est. completion date December 2018

Study information

Verified date October 2022
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Levosimendan
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

References & Publications (7)

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. — View 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):H233 — View 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 — View 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): — View 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. Review. — View 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. — View Citation

Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Event-free survival 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
Secondary functional changes (imaging) echocardiography and MRI examinations about LV function 12 months after coronary intervention due to the infarction
Secondary structural changes MRI examinations about fibrosis 12 months after coronary intervention due to the infarction
Secondary functional changes (spirometry) changes of capacity by spirometry. 12 months after coronary intervention due to the infarction
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