Clinical trial NCT02158468: Effect of Conditioning on Myocardial Damage in STEMI
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST-elevation Myocardial Infarction
Keywords: STEMI, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Myocardial salvage assessed by MRI
timeFrame: 1 week after infarction
Secondary outcomes:
measure: Composite of death, reinfarction and readmission for congestive heart failure
timeFrame: 6 months
Other outcomes:
measure: Infarct size assessed by MRI
timeFrame: 1 week after infarction
measure: Microvascular obstruction assessed by MRI
timeFrame: 1 week after infarction
Locations:
city: Leipzig
country: Germany
facility: University Leipzig - Heart Center, Department of Cardiology
state: Please Select
Study officials:
affiliation: University Leipzig- Heart Center
name: Ingo Eitel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botker HE, Kharbanda R, Schmidt MR, Bottcher 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, Sorensen 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.
citation: Lonborg J, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Treiman M, Jensen JS, Engstrom 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.
citation: Stiermaier T, Jensen JO, Rommel KP, de Waha-Thiele S, Fuernau G, Desch S, Thiele H, Eitel I. Combined Intrahospital Remote Ischemic Perconditioning and Postconditioning Improves Clinical Outcome in ST-Elevation Myocardial Infarction. Circ Res. 2019 May 10;124(10):1482-1491. doi: 10.1161/CIRCRESAHA.118.314500.
citation: Saad M, Stiermaier T, Fuernau G, Poss J, de Waha-Thiele S, Desch S, Thiele H, Eitel I. Impact of direct stenting on myocardial injury assessed by cardiac magnetic resonance imaging and prognosis in ST-elevation myocardial infarction. Int J Cardiol. 2019 May 15;283:88-92. doi: 10.1016/j.ijcard.2018.11.141. Epub 2018 Dec 3.
citation: Stiermaier T, Jobs A, de Waha S, Fuernau G, Poss J, Desch S, Thiele H, Eitel I. Optimized Prognosis Assessment in ST-Segment-Elevation Myocardial Infarction Using a Cardiac Magnetic Resonance Imaging Risk Score. Circ Cardiovasc Imaging. 2017 Nov;10(11):e006774. doi: 10.1161/CIRCIMAGING.117.006774.
citation: Reinstadler SJ, Stiermaier T, Liebetrau J, Fuernau G, Eitel C, de Waha S, Desch S, Reil JC, Poss J, Metzler B, Lucke C, Gutberlet M, Schuler G, Thiele H, Eitel I. Prognostic Significance of Remote Myocardium Alterations Assessed by Quantitative Noncontrast T1 Mapping in ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Imaging. 2018 Mar;11(3):411-419. doi: 10.1016/j.jcmg.2017.03.015. Epub 2017 Jun 14.
citation: Eitel I, Stiermaier T, Rommel KP, Fuernau G, Sandri M, Mangner N, Linke A, Erbs S, Lurz P, Boudriot E, Mende M, Desch S, Schuler G, Thiele H. Cardioprotection by combined intrahospital remote ischaemic perconditioning and postconditioning in ST-elevation myocardial infarction: the randomized LIPSIA CONDITIONING trial. Eur Heart J. 2015 Nov 21;36(44):3049-57. doi: 10.1093/eurheartj/ehv463. Epub 2015 Sep 17.