search
Back to results

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

Primary Purpose

Aortic Aneurysm

Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
preconditioning
Normal surgery, with sham intervention without inflating arm cuff
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm focused on measuring preconditioning, aortic aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aarhus University Hospital, SkejbyRecruiting
  • Aalborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Preconditioning and normal treatment

normal treatment

Arm Description

Standard treatment

Outcomes

Primary Outcome Measures

measurements of CKMB and Troponin T

Secondary Outcome Measures

Full Information

First Posted
January 30, 2012
Last Updated
January 12, 2015
Sponsor
Aarhus University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01523262
Brief Title
Preventing Myocardial Ischemia by Preconditioning in Elective Operation for Abdominal Aortic Aneurysm
Official Title
The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm
Keywords
preconditioning, aortic aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preconditioning and normal treatment
Arm Type
Active Comparator
Arm Title
normal treatment
Arm Type
Placebo Comparator
Arm Description
Standard treatment
Intervention Type
Procedure
Intervention Name(s)
preconditioning
Intervention Description
peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm
Intervention Type
Procedure
Intervention Name(s)
Normal surgery, with sham intervention without inflating arm cuff
Primary Outcome Measure Information:
Title
measurements of CKMB and Troponin T
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaj Eldrup
Email
eldrup@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Nikolaj Eldrup, MD, PHD
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Troels F Pedersen, MD
Email
troels.fogh@ki.au.dk
First Name & Middle Initial & Last Name & Degree
Troels F Pedersen, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs