We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00883363
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : January 14, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Abdominal Aortic Aneurysm Procedure: Precondition

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm
Study Start Date : April 2009
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Reduction in myocardial infarction [ Time Frame: 4 to 5 years ]

Secondary Outcome Measures :
  1. Improvement in survival Description on inflammatory response [ Time Frame: 4 to 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Technical inoperable
Contacts and Locations

Information from the National Library of Medicine

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): NCT00883363

Aarhus university hospital skejby department of cardio thoracic and vascular surgery
Aarhus, Region Midt, Denmark, 8200
Sponsors and Collaborators
Nikolaj Eldrup
Aarhus University Hospital
Aarhus University Hospital Skejby
Principal Investigator: Nikolaj Eldrup, MD PhD Aarhus University Hospital Skejby
More Information

Additional Information:
Responsible Party: Nikolaj Eldrup, MD PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00883363     History of Changes
Other Study ID Numbers: NE_RAAA_PRECON_01
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Nikolaj Eldrup, Aarhus University Hospital:
ruptured abdominal aortic aneurysm
myocardial infarction

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