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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02158468
Other study ID # LIPSIA-Conditioning
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date September 2014

Study information

Verified date December 2014
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date September 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany University Leipzig - Heart Center, Department of Cardiology Leipzig Please Select

Sponsors (1)

Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Infarct size assessed by MRI 1 week after infarction
Other Microvascular obstruction assessed by MRI 1 week after infarction
Primary Myocardial salvage assessed by MRI 1 week after infarction
Secondary Composite of death, reinfarction and readmission for congestive heart failure 6 months
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