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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Leipzig
Sponsor:
Information provided by (Responsible Party):
Ingo Eitel, University of Leipzig
ClinicalTrials.gov Identifier:
NCT02158468
First received: May 26, 2014
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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

Condition Intervention Phase
ST-elevation Myocardial Infarction
Device: Combined intrahospital pre- and postconditioning
Device: Postconditioning
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Conditioning on Myocardial Damage in ST-elevation Myocardial Infarction - Comparison of Combined Intrahospital Preconditioning Plus Postconditioning Versus Postconditioning Versus Control.

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Myocardial salvage assessed by MRI [ Time Frame: 1 week after infarction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite of death, reinfarction and readmission for congestive heart failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Infarct size assessed by MRI [ Time Frame: 1 week after infarction ] [ Designated as safety issue: No ]
  • Microvascular obstruction assessed by MRI [ Time Frame: 1 week after infarction ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
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)
Active Comparator: Postconditioning
4 cycles of postconditioning (30s ischemia, 30s reperfusion) after primary PCI/stenting
Device: Postconditioning
After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)
No Intervention: Control group
Standard infarction treatment without conditioning intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02158468

Locations
Germany
University Leipzig - Heart Center, Department of Cardiology Recruiting
Leipzig, Please Select, Germany, 04289
Contact: Ingo Eitel, MD    +49 3418650    ingoeitel@gmx.de   
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Ingo Eitel, MD University Leipzig- Heart Center
  More Information

Publications:
Responsible Party: Ingo Eitel, Ingo Eitel, MD, Associate Professor, University of Leipzig
ClinicalTrials.gov Identifier: NCT02158468     History of Changes
Other Study ID Numbers: LIPSIA-Conditioning
Study First Received: May 26, 2014
Last Updated: June 4, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Leipzig:
STEMI, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014