Effect of Conditioning on Myocardial Damage in STEMI

ST-elevation Myocardial Infarction Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158468
• Other study ID #: LIPSIA-Conditioning
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

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