Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00882622
Recruitment Status : Withdrawn (Endpoints were investigated in parallel in NCT00877305)
First Posted : April 16, 2009
Last Update Posted : January 18, 2012
University Hospital, Frankfurt
Information provided by (Responsible Party):
Patrick Meybohm, University of Schleswig-Holstein

Brief Summary:
The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Ventricular Arrythmias Myocardial Injury Cardiac Function Procedure: Remote Ischemic Preconditioning Procedure: Control/sham procedure Phase 1

Detailed Description:
In detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. Furthermore, we aim to investigate underlying pathways of RIPC in modifying the perioperative stress response.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
Study Start Date : February 2009
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: RIPC Procedure: Remote Ischemic Preconditioning
RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line.
Sham Comparator: CONTROL Procedure: Control/sham procedure
Sham placement of the blood pressure cuff around the upper limb without inflation.

Primary Outcome Measures :
  1. New onset of atrial fibrillation [ Time Frame: Within 30 days after surgery ]

Secondary Outcome Measures :
  1. Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response. [ Time Frame: Within 24 hours after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

  • Emergency cases
  • Myocardial infarction up to 7 days prior to enrollment
  • Ejection fraction less than 30%
  • Inability to give informed consent

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 identifier (NCT number): NCT00882622

University Hospital
Frankfurt am Main, Germany
University Hospital Schleswig-Holstein
Kiel, Germany, 24105
Sponsors and Collaborators
Patrick Meybohm
University Hospital, Frankfurt

Responsible Party: Patrick Meybohm, PD Dr., University of Schleswig-Holstein Identifier: NCT00882622     History of Changes
Other Study ID Numbers: A165/08_2
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Patrick Meybohm, University of Schleswig-Holstein:
Ischemic Preconditioning
Cardiac Surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes