Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

NCT ID: NCT00883363

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-12-31

Brief Summary

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Preconditioning in patients treated for elective abdominal aneurysm showed that the rate of perioperative myocardial infarction could be reduced by 80 %(ARR from 27% to 5%). Precondition where performed by 10 minutes of clamping of each iliac arteries before clamping the abdominal aorta. Human studies in cardiac patients have shown promising results with precondition. Instead of clamping arteries they have all performed the procedure by inflating a blood pressure cuff above arterial pressure on a arm.

The investigators want to investigate if preconditioning induced by a blood pressure cuff on a arm can reduce the perioperative rate of myocardial infarction in patients open operated for ruptured abdominal aortic aneurysm.

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Precondition

Induction of precondition at start of operation on a arm

Group Type EXPERIMENTAL

Precondition

Intervention Type PROCEDURE

Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm

Control

No precondition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Precondition

Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with ruptured abdominal aortic aneurysm offered surgery
* Age \> 18 years

Exclusion Criteria

* Technical inoperable
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital Skejby

OTHER

Sponsor Role collaborator

Nikolaj Eldrup

OTHER

Sponsor Role lead

Responsible Party

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Nikolaj Eldrup

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nikolaj Eldrup, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby

Locations

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Aarhus university hospital skejby department of cardio thoracic and vascular surgery

Aarhus, Region Midt, Denmark

Site Status

Countries

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Denmark

References

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Pedersen TF, Budtz-Lilly J, Petersen CN, Hyldgaard J, Schmidt JO, Kroijer R, Gronholdt ML, Eldrup N. Randomized clinical trial of remote ischaemic preconditioning versus no preconditioning in the prevention of perioperative myocardial infarction during open surgery for ruptured abdominal aortic aneurysm. BJS Open. 2018 Mar 26;2(3):112-118. doi: 10.1002/bjs5.55. eCollection 2018 Jun.

Reference Type DERIVED
PMID: 29951634 (View on PubMed)

Related Links

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http://web.me.com/eldrup/forsk/

Study homepage with information

Other Identifiers

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NE_RAAA_PRECON_01

Identifier Type: -

Identifier Source: org_study_id

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