Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
Primary Purpose
Atrial Fibrillation, Ventricular Arrythmias, Myocardial Injury
Status
Withdrawn
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Control/sham procedure
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Ischemic Preconditioning, Cardiac Surgery
Eligibility Criteria
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
Sites / Locations
- University Hospital
- University Hospital Schleswig-Holstein
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
RIPC
CONTROL
Arm Description
Outcomes
Primary Outcome Measures
New onset of atrial fibrillation
Secondary Outcome Measures
Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response.
Full Information
NCT ID
NCT00882622
First Posted
April 14, 2009
Last Updated
January 17, 2012
Sponsor
Patrick Meybohm
Collaborators
Goethe University
1. Study Identification
Unique Protocol Identification Number
NCT00882622
Brief Title
Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
Official Title
Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Endpoints were investigated in parallel in NCT00877305
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Meybohm
Collaborators
Goethe University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Ventricular Arrythmias, Myocardial Injury, Cardiac Function
Keywords
Ischemic Preconditioning, Cardiac Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIPC
Arm Type
Active Comparator
Arm Title
CONTROL
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control/sham procedure
Intervention Description
Sham placement of the blood pressure cuff around the upper limb without inflation.
Primary Outcome Measure Information:
Title
New onset of atrial fibrillation
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital
City
Frankfurt am Main
Country
Germany
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
12. IPD Sharing Statement
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Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
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