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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883363
First Posted: April 17, 2009
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aarhus University Hospital
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
Nikolaj Eldrup, Aarhus University Hospital
April 15, 2009
April 17, 2009
January 14, 2015
April 2009
December 2014   (Final data collection date for primary outcome measure)
Reduction in myocardial infarction [ Time Frame: 4 to 5 years ]
Same as current
Complete list of historical versions of study NCT00883363 on ClinicalTrials.gov Archive Site
Improvement in survival Description on inflammatory response [ Time Frame: 4 to 5 years ]
Same as current
Not Provided
Not Provided
 
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
Procedure: Precondition
Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm
  • Experimental: Precondition
    Induction of precondition at start of operation on a arm
    Intervention: Procedure: Precondition
  • No Intervention: Control
    No precondition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Technical inoperable
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00883363
NE_RAAA_PRECON_01
No
Not Provided
Not Provided
Nikolaj Eldrup, Aarhus University Hospital
Nikolaj Eldrup
  • Aarhus University Hospital
  • Aarhus University Hospital Skejby
Principal Investigator: Nikolaj Eldrup, MD PhD Aarhus University Hospital Skejby
Aarhus University Hospital
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP