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

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ClinicalTrials.gov Identifier: NCT02158468
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Leipzig

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

Condition or disease Intervention/treatment Phase
ST-elevation Myocardial Infarction Device: Combined intrahospital pre- and postconditioning Device: Postconditioning Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Myocardial salvage assessed by MRI [ Time Frame: 1 week after infarction ]

Secondary Outcome Measures :
  1. Composite of death, reinfarction and readmission for congestive heart failure [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Infarct size assessed by MRI [ Time Frame: 1 week after infarction ]
  2. Microvascular obstruction assessed by MRI [ Time Frame: 1 week after infarction ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158468


Locations
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Germany
University Leipzig - Heart Center, Department of Cardiology
Leipzig, Please Select, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Ingo Eitel, MD University Leipzig- Heart Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Leipzig
ClinicalTrials.gov Identifier: NCT02158468    
Other Study ID Numbers: LIPSIA-Conditioning
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: December 2014
Keywords provided by University of Leipzig:
STEMI, reperfusion, preconditioning, postconditioning, reperfusion injury, myocardial salvage
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases