Skip to main content
OpenTrials
Completed

NCT Number: NCT02158468

Effect of Conditioning on Myocardial Damage in STEMI

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ST-elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Leipzig - Heart Center, Department of Cardiology

Leipzig, Please Select, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined intrahospital pre- and postconditioning

Device

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)

Postconditioning

Device

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

Primary outcomes

  1. Myocardial salvage assessed by MRI

    Time frame: 1 week after infarction

Secondary outcomes

  1. Composite of death, reinfarction and readmission for congestive heart failure

    Time frame: 6 months

Other outcomes

  1. Infarct size assessed by MRI

    Time frame: 1 week after infarction

  2. Microvascular obstruction assessed by MRI

    Time frame: 1 week after infarction

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: LIPSIA-COND

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2014
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.