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NCT00883363 Clinical Trial

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

Abdominal Aortic Aneurysm Clinical Trial

— PreconRAAA  

Official title:
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00883363
Other study ID # NE_RAAA_PRECON_01
Secondary ID
Status Completed
Phase N/A
First received April 15, 2009
Last updated January 12, 2015
Start date April 2009
Est. completion date December 2014

Study information
Verified date January 2015
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with ruptured abdominal aortic aneurysm offered surgery

- Age > 18 years

Exclusion Criteria:

- Technical inoperable

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Precondition
Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm

Locations
Country Name City State
Denmark Aarhus university hospital skejby department of cardio thoracic and vascular surgery Aarhus Region Midt

Sponsors (3)
Lead Sponsor Collaborator
Nikolaj Eldrup Aarhus University Hospital, Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in myocardial infarction 4 to 5 years No
Secondary Improvement in survival Description on inflammatory response 4 to 5 years No
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