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

This study is currently recruiting participants.
Verified January 2012 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Nikolaj Eldrup, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01523262
First received: January 30, 2012
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Aortic Aneurysm
 Procedure: preconditioning
Procedure: Normal surgery, with sham intervention without inflating arm cuff
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • measurements of CKMB and Troponin T [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Procedure: Normal surgery, with sham intervention without inflating arm cuff

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523262

Locations
Denmark
Aarhus University Hospital, Skejby Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Nikolaj Eldrup         eldrup@ki.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

No publications provided

Responsible Party: Nikolaj Eldrup, MD, PHD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01523262     History of Changes
Other Study ID Numbers: M-20100012
Study First Received: January 30, 2012
Last Updated: January 31, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:
preconditioning
aortic aneurysm

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

ClinicalTrials.gov processed this record on May 23, 2013