Effect of Conditioning on Myocardial Damage in STEMI

NCT ID: NCT02158468

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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

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ST-elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Combined intrahospital pre- and postconditioning

Intervention Type DEVICE

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)

Postconditioning

4 cycles of postconditioning (30s ischemia, 30s reperfusion) after primary PCI/stenting

Group Type ACTIVE_COMPARATOR

Postconditioning

Intervention Type DEVICE

After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)

Control group

Standard infarction treatment without conditioning intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DEVICE

Postconditioning

After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingo Eitel, MD

Role: PRINCIPAL_INVESTIGATOR

University Leipzig- Heart Center

Locations

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University Leipzig - Heart Center, Department of Cardiology

Leipzig, Please Select, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 20189026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20118154 (View on PubMed)

Lange T, Gertz RJ, Schulz A, Backhaus SJ, Evertz R, Kowallick JT, Hasenfuss G, Desch S, Thiele H, Stiermaier T, Eitel I, Schuster A. Impact of myocardial deformation on risk prediction in patients following acute myocardial infarction. Front Cardiovasc Med. 2023 Aug 10;10:1199936. doi: 10.3389/fcvm.2023.1199936. eCollection 2023.

Reference Type DERIVED
PMID: 37636296 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30929570 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30573280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29122844 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28624398 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26385956 (View on PubMed)

Other Identifiers

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LIPSIA-Conditioning

Identifier Type: -

Identifier Source: org_study_id

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