Preventing Myocardial Ischemia by Preconditioning in Elective Operation for Abdominal Aortic Aneurysm

NCT ID: NCT01523262

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-01-31

Brief Summary

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Primary To investigate whether peripheral predonditioning induced by brief, intermittent constriction of blood supply to an arm can reduce the incidence of perioperative myocardial ischemia in patients operated electively for infrarenal aortic aneurysm.

Secondary To investigate the impact of peripheral preconditioning on perioperative inflammatory response.

To investigate whether peripheral preconditoning can protect against perioperative myocardial infarction and reduced cardiac pump function.

Detailed Description

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Conditions

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Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Preconditioning and normal treatment

Group Type ACTIVE_COMPARATOR

preconditioning

Intervention Type PROCEDURE

peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm

normal treatment

Standard treatment

Group Type PLACEBO_COMPARATOR

Normal surgery, with sham intervention without inflating arm cuff

Intervention Type PROCEDURE

Interventions

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preconditioning

peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm

Intervention Type PROCEDURE

Normal surgery, with sham intervention without inflating arm cuff

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients older than 18 years, hospitalized for elective surgery of abdominal aortic aneurysm

Exclusion Criteria

* Lack of informed consent.
* Hemiparetic patient.
* Pregnancy or nursing patient.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nikolaj Eldrup

MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aalborg Hospital

Aalborg, Aalborg, Denmark

Site Status NOT_YET_RECRUITING

Aarhus University Hospital, Skejby

Aarhus, Aarhus N, Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Troels F Pedersen, MD

Role: primary

Nikolaj Eldrup

Role: primary

References

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Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

Reference Type DERIVED
PMID: 36645250 (View on PubMed)

Other Identifiers

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M-20100012

Identifier Type: -

Identifier Source: org_study_id

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