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Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm (PreconRAAA)

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Precondition
Sponsored by
Nikolaj Eldrup
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring precondition, ruptured abdominal aortic aneurysm, myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Technical inoperable

Sites / Locations

  • Aarhus university hospital skejby department of cardio thoracic and vascular surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Precondition

Control

Arm Description

Induction of precondition at start of operation on a arm

No precondition

Outcomes

Primary Outcome Measures

Reduction in myocardial infarction

Secondary Outcome Measures

Improvement in survival Description on inflammatory response

Full Information

First Posted
April 15, 2009
Last Updated
January 12, 2015
Sponsor
Nikolaj Eldrup
Collaborators
Aarhus University Hospital, Aarhus University Hospital Skejby
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1. Study Identification

Unique Protocol Identification Number
NCT00883363
Brief Title
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm
Acronym
PreconRAAA
Official Title
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nikolaj Eldrup
Collaborators
Aarhus University Hospital, Aarhus University Hospital Skejby

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
precondition, ruptured abdominal aortic aneurysm, myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precondition
Arm Type
Experimental
Arm Description
Induction of precondition at start of operation on a arm
Arm Title
Control
Arm Type
No Intervention
Arm Description
No precondition
Intervention Type
Procedure
Intervention Name(s)
Precondition
Intervention Description
Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm
Primary Outcome Measure Information:
Title
Reduction in myocardial infarction
Time Frame
4 to 5 years
Secondary Outcome Measure Information:
Title
Improvement in survival Description on inflammatory response
Time Frame
4 to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ruptured abdominal aortic aneurysm offered surgery Age > 18 years Exclusion Criteria: Technical inoperable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaj Eldrup, MD PhD
Organizational Affiliation
Aarhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus university hospital skejby department of cardio thoracic and vascular surgery
City
Aarhus
State/Province
Region Midt
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29951634
Citation
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.
Results Reference
derived
Links:
URL
http://web.me.com/eldrup/forsk/
Description
Study homepage with information

Learn more about this trial

Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

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