MedTrace Logo

Acute and Chronic Protective Effects of Peri-interventional Administration of Levosimendan in ST Elevation Myocardial Infarctions

NCT03022877 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Michael Becker · Cardiology, RWTH University Hospital Aachen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2018-12-31
Completion
2018-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03022877 on ClinicalTrials.gov