ST-elevation Myocardial Infarction
Conditions
Keywords
STEMI, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage
Brief 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.
Interventions
DEVICECombined 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)
DEVICEPostconditioning
After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial salvage assessed by MRI | 1 week after infarction |
Secondary
| Measure | Time frame |
|---|---|
| Composite of death, reinfarction and readmission for congestive heart failure | 6 months |
Other
| Measure | Time frame |
|---|---|
| Infarct size assessed by MRI | 1 week after infarction |
| Microvascular obstruction assessed by MRI | 1 week after infarction |
Countries
Germany
Outcome results
None listed