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

January 12, 2015 updated by: Nikolaj Eldrup

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

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
    • Region Midt
      • Aarhus, Region Midt, Denmark, 8200
        • Aarhus university hospital skejby department of cardio thoracic and vascular surgery

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:

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

Exclusion Criteria:

  • Technical inoperable

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Precondition
Induction of precondition at start of operation on a arm
Procedure: Precondition
Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm
No Intervention: Control
No precondition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in myocardial infarction
Time Frame: 4 to 5 years
4 to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in survival Description on inflammatory response
Time Frame: 4 to 5 years
4 to 5 years

Collaborators and Investigators

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

Sponsor

Nikolaj Eldrup

Collaborators

Aarhus University Hospital
Aarhus University Hospital Skejby

Investigators

  • Principal Investigator: Nikolaj Eldrup, MD PhD, Aarhus University Hospital Skejby

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

April 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 17, 2009

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

  • NE_RAAA_PRECON_01

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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