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

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ClinicalTrials.gov Identifier: NCT01523262
Recruitment Status : Unknown
Verified January 2015 by Nikolaj Eldrup, Aarhus University Hospital.
Recruitment status was:  Recruiting
First Posted : February 1, 2012
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Nikolaj Eldrup, Aarhus University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Aortic Aneurysm Procedure: preconditioning Procedure: Normal surgery, with sham intervention without inflating arm cuff Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm
Study Start Date : January 2011
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2016

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. measurements of CKMB and Troponin T [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523262


Locations
Denmark
Aarhus University Hospital, Skejby Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Nikolaj Eldrup       eldrup@clin.au.dk   
Sub-Investigator: Nikolaj Eldrup, MD, PHD         
Aalborg Hospital Not yet recruiting
Aalborg, Denmark, 9000
Contact: Troels F Pedersen, MD       troels.fogh@ki.au.dk   
Principal Investigator: Troels F Pedersen, MD         
Sponsors and Collaborators
Aarhus University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nikolaj Eldrup, MD, PHD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01523262     History of Changes
Other Study ID Numbers: M-20100012
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Nikolaj Eldrup, Aarhus University Hospital:
preconditioning
aortic aneurysm

Additional relevant MeSH terms:
Ischemia
Aneurysm
Aortic Aneurysm
Myocardial Ischemia
Coronary Artery Disease
Aortic Aneurysm, Abdominal
Pathologic Processes
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases