Effect of Conditioning on Myocardial Damage in STEMI (LIPSIA-COND)

University of Leipzig

Status: Completed

Conditions: ST-elevation Myocardial Infarction

Treatments: Device: Postconditioning; Device: Combined intrahospital pre- and postconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02158468

LIPSIA-Conditioning

Details and patient eligibility

About

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

Full description

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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Combined intrahospital pre- and postconditioning

Active Comparator group

Description:

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).

Treatment:

Device: Combined intrahospital pre- and postconditioning

Postconditioning

Active Comparator group

Description:

4 cycles of postconditioning (30s ischemia, 30s reperfusion) after primary PCI/stenting

Treatment:

Device: Postconditioning

Control group

No Intervention group

Description:

Standard infarction treatment without conditioning intervention