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Effect of Conditioning on Myocardial Damage in STEMI (LIPSIA-COND)

Primary Purpose

ST-elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Combined intrahospital pre- and postconditioning
Postconditioning
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring STEMI, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Leipzig - Heart Center, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Combined intrahospital pre- and postconditioning

Postconditioning

Control group

Arm Description

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).

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

Standard infarction treatment without conditioning intervention

Outcomes

Primary Outcome Measures

Myocardial salvage assessed by MRI

Secondary Outcome Measures

Composite of death, reinfarction and readmission for congestive heart failure

Full Information

First Posted
May 26, 2014
Last Updated
June 22, 2018
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT02158468
Brief Title
Effect of Conditioning on Myocardial Damage in STEMI
Acronym
LIPSIA-COND
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leipzig

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Combined intrahospital pre- plus postconditioning versus Postconditioning versus 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction
Keywords
STEMI, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined intrahospital pre- and postconditioning
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Postconditioning
Arm Type
Active Comparator
Arm Description
4 cycles of postconditioning (30s ischemia, 30s reperfusion) after primary PCI/stenting
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard infarction treatment without conditioning intervention
Intervention Type
Device
Intervention Name(s)
Combined intrahospital pre- and postconditioning
Intervention Description
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
Intervention Name(s)
Postconditioning
Intervention Description
After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)
Primary Outcome Measure Information:
Title
Myocardial salvage assessed by MRI
Time Frame
1 week after infarction
Secondary Outcome Measure Information:
Title
Composite of death, reinfarction and readmission for congestive heart failure
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Infarct size assessed by MRI
Time Frame
1 week after infarction
Title
Microvascular obstruction assessed by MRI
Time Frame
1 week after infarction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingo Eitel, MD
Organizational Affiliation
University Leipzig- Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Leipzig - Heart Center, Department of Cardiology
City
Leipzig
State/Province
Please Select
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20189026
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.
Results Reference
background
PubMed Identifier
20118154
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.
Results Reference
background
PubMed Identifier
30929570
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.
Results Reference
derived
PubMed Identifier
30573280
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.
Results Reference
derived
PubMed Identifier
29122844
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.
Results Reference
derived
PubMed Identifier
28624398
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.
Results Reference
derived
PubMed Identifier
26385956
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.
Results Reference
derived

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Effect of Conditioning on Myocardial Damage in STEMI

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