Effect of Conditioning on Myocardial Damage in STEMI

Study Overview
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Brief Summary
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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: Combined intrahospital pre- plus postconditioning versus Postconditioning versus Control

Detailed Description
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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.

Official Title
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Effect of Conditioning on Myocardial Damage in ST-elevation Myocardial Infarction - Comparison of Combined Intrahospital Preconditioning Plus Postconditioning Versus Postconditioning Versus Control.

Conditions
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ST-elevation Myocardial Infarction

Intervention / Treatment
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* Device: Combined intrahospital pre- and postconditioning
* Device: Postconditioning


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combined intrahospital pre- and postconditioning<br>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). | Device: Combined intrahospital pre- and postconditioning<br>* 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)<br>|
| Active Comparator: Postconditioning<br>4 cycles of postconditioning (30s ischemia, 30s reperfusion) after primary PCI/stenting | Device: Postconditioning<br>* After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)<br>|
| No Intervention: Control group<br>Standard infarction treatment without conditioning intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial salvage assessed by MRI |  | 1 week after infarction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death, reinfarction and readmission for congestive heart failure |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage