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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Withdrawn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
Patrick Meybohm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Ischemic Preconditioning, Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 14, 2009
Last Updated
January 17, 2012
Sponsor
Patrick Meybohm
Collaborators
Goethe University
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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Withdrawn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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