Trials / Completed
CompletedNCT02158468
Effect of Conditioning on Myocardial Damage in STEMI
Effect of Conditioning on Myocardial Damage in ST-elevation Myocardial Infarction - Comparison of Combined Intrahospital Preconditioning Plus Postconditioning Versus Postconditioning Versus Control.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- University of Leipzig · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
| DEVICE | Postconditioning | After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion) |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2014-08-01
- Completion
- 2014-09-01
- First posted
- 2014-06-06
- Last updated
- 2018-06-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02158468. Inclusion in this directory is not an endorsement.