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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Aarhus University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Nikolaj Eldrup, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00883363
First received: April 15, 2009
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysm
Procedure: Precondition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Reduction in myocardial infarction [ Time Frame: 4 to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in survival Description on inflammatory response [ Time Frame: 4 to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: Precondition
Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Technical inoperable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883363

Contacts
Contact: Nikolaj Eldrup, MD PhD +4528947946 eldrup@ki.au.dk
Contact: William Paaske, MD DMSC Professor +4589495566 william@paaske.org

Locations
Denmark
Aarhus university hospital skejby department of cardio thoracic and vascular surgery Recruiting
Aarhus, Denmark, 8200
Contact: Nikolaj Eldrup, MD PhD       eldrup@ki.au.dk   
Sponsors and Collaborators
Nikolaj Eldrup
Aarhus University Hospital
Investigators
Principal Investigator: Nikolaj Eldrup, MD PhD Aarhus University Hospital Skejby
  More Information

Additional Information:
No publications provided

Responsible Party: Nikolaj Eldrup, MD PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00883363     History of Changes
Other Study ID Numbers: NE_RAAA_PRECON_01
Study First Received: April 15, 2009
Last Updated: January 30, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:
precondition
ruptured abdominal aortic aneurysm
myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Rupture
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aortic Diseases
Aneurysm, Ruptured
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014