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

January 12, 2015 updated by: Nikolaj Eldrup, Aarhus University Hospital

The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Not yet recruiting
        • Aalborg Hospital
        • Contact:
        • Principal Investigator:
          • Troels F Pedersen, MD
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital, Skejby
        • Contact:
        • Sub-Investigator:
          • Nikolaj Eldrup, MD, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Preconditioning and normal treatment
Procedure: preconditioning
peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm
Placebo Comparator: normal treatment
Standard treatment
Procedure: Normal surgery, with sham intervention without inflating arm cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measurements of CKMB and Troponin T
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 30, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20100012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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