NCT01523262

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

4 years

First QC Date

January 30, 2012

Last Update Submit

January 12, 2015

Conditions

Aortic Aneurysm

Keywords

preconditioningaortic aneurysm

Outcome Measures

Primary Outcomes (1)

  • measurements of CKMB and Troponin T

    30 days

Study Arms (2)

Preconditioning and normal treatment

ACTIVE COMPARATOR
Procedure: preconditioning

normal treatment

PLACEBO COMPARATOR

Standard treatment

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

Interventions

preconditioningPROCEDURE

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

Preconditioning and normal treatment
Normal surgery, with sham intervention without inflating arm cuffPROCEDURE
normal treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aalborg Hospital

Aalborg, Aalborg, 9000, Denmark

NOT YET RECRUITING

Aarhus University Hospital, Skejby

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36645250DERIVED

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 1, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

DK(2)