NCT02158468

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. 1.Combined intrahospital pre- plus postconditioning versus
  2. 2.Postconditioning versus
  3. 3.Control

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 26, 2018

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

May 26, 2014

Last Update Submit

June 22, 2018

Conditions

ST-elevation Myocardial Infarction

Keywords

STEMI, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage

Outcome Measures

Primary Outcomes (1)

  • Myocardial salvage assessed by MRI

    1 week after infarction

Secondary Outcomes (1)

  • Composite of death, reinfarction and readmission for congestive heart failure

    6 months

Other Outcomes (2)

  • Infarct size assessed by MRI

    1 week after infarction

  • Microvascular obstruction assessed by MRI

    1 week after infarction

Study Arms (3)

Combined intrahospital pre- and postconditioning

ACTIVE COMPARATOR

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: Combined intrahospital pre- and postconditioning

Postconditioning

ACTIVE COMPARATOR

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

Device: Postconditioning

Control group

NO INTERVENTION

Standard infarction treatment without conditioning intervention

Interventions

Combined intrahospital pre- and postconditioningDEVICE

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)

Combined intrahospital pre- and postconditioning
PostconditioningDEVICE

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

Postconditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ST-elevation myocardial infarction \<12 hours

You may not qualify if:

  • Age ≤ 18 years
  • Patients presenting with pregnancy
  • Thrombolysis \<12 hours
  • Patients without informed consent
  • Participation in another trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Leipzig - Heart Center, Department of Cardiology

Leipzig, Please Select, 04289, Germany

Location

Related Publications (8)

  • 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.

    PMID: 20189026BACKGROUND

  • 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.

    PMID: 20118154BACKGROUND

  • 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.

    PMID: 37636296DERIVED

  • 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.

    PMID: 30929570DERIVED

  • 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.

    PMID: 30573280DERIVED

  • 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.

    PMID: 29122844DERIVED

  • 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.

    PMID: 28624398DERIVED

  • 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.

    PMID: 26385956DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionReperfusion Injury

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPostoperative Complications

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ingo Eitel, MD

    University Leipzig- Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

June 6, 2014

Study Start

October 1, 2011

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

June 26, 2018

Record last verified: 2014-12

Locations

DE(1)