Effect of Conditioning on Myocardial Damage in STEMI

Overview

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 Title of Study: “Effect of Conditioning on Myocardial Damage in ST-elevation Myocardial Infarction – Comparison of Combined Intrahospital Preconditioning Plus Postconditioning Versus Postconditioning Versus Control.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

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

  • 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)

Arms, Groups and Cohorts

  • 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).
  • Active Comparator: Postconditioning
    • 4 cycles of postconditioning (30s ischemia, 30s reperfusion) after primary PCI/stenting
  • No Intervention: Control group
    • Standard infarction treatment without conditioning intervention

Clinical Trial Outcome Measures

Primary Measures

  • Myocardial salvage assessed by MRI
    • Time Frame: 1 week after infarction

Secondary Measures

  • Composite of death, reinfarction and readmission for congestive heart failure
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Leipzig
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ingo Eitel, MD, Principal Investigator, University Leipzig- Heart Center

References

Bøtker HE, Kharbanda R, Schmidt MR, Bøttcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sørensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.

Lønborg J, Kelbaek H, Vejlstrup N, Jørgensen E, Helqvist S, Saunamäki K, Clemmensen P, Holmvang L, Treiman M, Jensen JS, Engstrøm T. Cardioprotective effects of ischemic postconditioning in patients treated with primary percutaneous coronary intervention, evaluated by magnetic resonance. Circ Cardiovasc Interv. 2010 Feb 1;3(1):34-41. doi: 10.1161/CIRCINTERVENTIONS.109.905521. Epub 2010 Jan 26.

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