Effect of Conditioning on Myocardial Damage in STEMI (LIPSIA-COND)
|ClinicalTrials.gov Identifier: NCT02158468|
Recruitment Status : Unknown
Verified June 2014 by Ingo Eitel, University of Leipzig.
Recruitment status was: Recruiting
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|ST-elevation Myocardial Infarction||Device: Combined intrahospital pre- and postconditioning Device: Postconditioning||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Conditioning on Myocardial Damage in ST-elevation Myocardial Infarction - Comparison of Combined Intrahospital Preconditioning Plus Postconditioning Versus Postconditioning Versus Control.|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||September 2014|
Active Comparator: Combined intrahospital pre- and postconditioning
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
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)
Active Comparator: Postconditioning
4 cycles of postconditioning (30s ischemia, 30s reperfusion) after primary PCI/stenting
After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)
No Intervention: Control group
Standard infarction treatment without conditioning intervention
- Myocardial salvage assessed by MRI [ Time Frame: 1 week after infarction ]
- Composite of death, reinfarction and readmission for congestive heart failure [ Time Frame: 6 months ]
- Infarct size assessed by MRI [ Time Frame: 1 week after infarction ]
- Microvascular obstruction assessed by MRI [ Time Frame: 1 week after infarction ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158468
|University Leipzig - Heart Center, Department of Cardiology||Recruiting|
|Leipzig, Please Select, Germany, 04289|
|Contact: Ingo Eitel, MD +49 3418650 email@example.com|
|Principal Investigator:||Ingo Eitel, MD||University Leipzig- Heart Center|