NCT00882622

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

April 14, 2009

Last Update Submit

January 17, 2012

Conditions

Atrial FibrillationVentricular ArrythmiasMyocardial InjuryCardiac Function

Keywords

Ischemic PreconditioningCardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • New onset of atrial fibrillation

    Within 30 days after surgery

Secondary Outcomes (1)

  • Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response.

    Within 24 hours after surgery

Study Arms (2)

RIPC

ACTIVE COMPARATOR
Procedure: Remote Ischemic Preconditioning

CONTROL

SHAM COMPARATOR
Procedure: Control/sham procedure

Interventions

Remote Ischemic PreconditioningPROCEDURE

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.

RIPC
Control/sham procedurePROCEDURE

Sham placement of the blood pressure cuff around the upper limb without inflation.

CONTROL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing heart surgery on cardiopulmonary bypass

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital

Frankfurt am Main, Germany

Location

University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr.

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 16, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

DE(2)