Effect of Conditioning on Myocardial Damage in STEMI

University of Leipzig600 enrolled

Overview

The LIPSIA-Conditioning trial is an investigater initiated, randomized, single-center study that will assess the effect of different intrahospital conditioning protocols on myocardial damage assessed by MRI in patients with acute ST-elevation myocardial infarction. The following groups will be compared: 1. Combined intrahospital pre- plus postconditioning versus 2. Postconditioning versus 3. Control

Rapid reperfusion of the infarct-related coronary artery is essential to salvage ischemic myocardium in patients with acute ST-elevation myocardial infarction (STEMI). Paradoxically, restoration of the blood flow to the ischemic area may result in further injury to the myocardium. This phenomenon is described as 'ischemia/reperfusion injury' and the pathophysiological mechanisms are not fully elucidated. A cardioprotective effect of ischemic preconditioning as well for postconditioning (short repetitive cycles of reperfusion and re-occlusion) has been demonstrated in experimental studies and in pilot studies on patients with acute STEMI treated with primary percutaneous coronary intervention. Aim of this study is to compare for the first time the combination of intrahospital pre- and postconditioning versus exclusive postconditioning versus control. The primary endpoint of this study will be the salvaged area at risk assessed by cardiac magnetic resonance imaging.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

ST-elevation Myocardial Infarction

Interventions

Combined intrahospital pre- and postconditioningDEVICE

After admission to hospital 3 cycles of preconditioning with 5-min inflation and 5-min deflation of a blood-pressure cuff. After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)

PostconditioningDEVICE

After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: ST-elevation myocardial infarction \<12 hours Exclusion Criteria: * Age ≤ 18 years * Patients presenting with pregnancy * Thrombolysis \<12 hours * Patients without informed consent * Participation in another trial.

Locations (1)

University Leipzig - Heart Center, Department of Cardiology

Leipzig, Please Select, Germany

Outcomes

Primary Outcomes

Myocardial salvage assessed by MRI

Time frame: 1 week after infarction

Secondary Outcomes

Composite of death, reinfarction and readmission for congestive heart failure

Time frame: 6 months

Data from ClinicalTrials.gov

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