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Status unknownNCT01523262Updated Jan 14, 2015

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

A Phase 1 interventional study of preconditioning and Normal surgery, with sham intervention without inflating arm cuff in Aortic Aneurysm, sponsored by Aarhus University Hospital. Status unknown at 2 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by Aarhus University Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Lack of informed consent.
  • Hemiparetic patient.
  • Pregnancy or nursing patient.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Preconditioning and normal treatment

    Procedure: preconditioning

  • Placebo comparator
    normal treatment

    Standard treatment

    Procedure: Normal surgery, with sham intervention without inflating arm cuff

Interventions

  • Procedurepreconditioning

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

  • ProcedureNormal surgery, with sham intervention without inflating arm cuff
06

What researchers measure

Primary outcomes

  1. measurements of CKMB and Troponin T

    Time frame: 30 days

07

Study locations

1 of 2 sites recruiting
  • Aarhus University Hospital, Skejby
    Aarhus, Aarhus N 8200, Denmark
    • Nikolaj Eldrup · Contact · eldrup@clin.au.dk
    • Nikolaj Eldrup, MD, PHD · Sub investigator
    Recruiting
  • Aalborg Hospital
    Aalborg, 9000, Denmark
    • Troels F Pedersen, MD · Contact · troels.fogh@ki.au.dk
    • Troels F Pedersen, MD · Principal investigator
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01523262
Lead sponsor
Aarhus University Hospital
Responsible party
Nikolaj Eldrup (MD, PHD, Aarhus University Hospital) — Principal investigator
First posted
Feb 1, 2012
Start date
Jan 2011
Primary completion
Jan 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jan 14, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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