NCT00883363

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

5.7 years

First QC Date

April 15, 2009

Last Update Submit

January 12, 2015

Conditions

Keywords

preconditionruptured abdominal aortic aneurysmmyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Reduction in myocardial infarction

    4 to 5 years

Secondary Outcomes (1)

  • Improvement in survival Description on inflammatory response

    4 to 5 years

Study Arms (2)

Precondition

EXPERIMENTAL

Induction of precondition at start of operation on a arm

Procedure: Precondition

Control

NO INTERVENTION

No precondition

Interventions

PreconditionPROCEDURE

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

Precondition

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Technical inoperable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus university hospital skejby department of cardio thoracic and vascular surgery

Aarhus, Region Midt, 8200, Denmark

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalMyocardial Infarction

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Nikolaj Eldrup, MD PhD

    Aarhus University Hospital Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 17, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations