Trial record 2 of 144 for:
"Abdominal aortic aneurysm"
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm (PreconRAAA)
This study is currently recruiting participants.
Verified January 2012 by Aarhus University Hospital
Sponsor:
Nikolaj Eldrup
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
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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
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 |
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:
|
Aneurysm Aortic Aneurysm Infarction Myocardial Infarction Aortic Aneurysm, Abdominal Rupture Vascular Diseases Cardiovascular Diseases |
Aortic Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013