Preventing Myocardial Ischemia by Preconditioning in Elective Operation for Abdominal Aortic Aneurysm
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 by Aarhus University Hospital
Sponsor:
Aarhus University Hospital
Information provided by (Responsible Party):
Nikolaj Eldrup, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01523262
First received: January 30, 2012
Last updated: January 12, 2015
Last verified: January 2015
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Purpose
Primary To investigate whether peripheral predonditioning induced by brief, intermittent constriction of blood supply to an arm can reduce the incidence of perioperative myocardial ischemia in patients operated electively for infrarenal aortic aneurysm.
Secondary To investigate the impact of peripheral preconditioning on perioperative inflammatory response.
To investigate whether peripheral preconditoning can protect against perioperative myocardial infarction and reduced cardiac pump function.
| Condition | Intervention | Phase |
|---|---|---|
|
Aortic Aneurysm |
Procedure: preconditioning Procedure: Normal surgery, with sham intervention without inflating arm cuff |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm |
Resource links provided by NLM:
Further study details as provided by Aarhus University Hospital:
Primary Outcome Measures:
- measurements of CKMB and Troponin T [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Preconditioning and normal treatment |
Procedure: preconditioning
peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm
|
|
Placebo Comparator: normal treatment
Standard treatment
|
Procedure: Normal surgery, with sham intervention without inflating arm cuff |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- All patients older than 18 years, hospitalized for elective surgery of abdominal aortic aneurysm
Exclusion Criteria:
- Lack of informed consent.
- Hemiparetic patient.
- Pregnancy or nursing patient.
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: NCT01523262
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523262
Locations
| Denmark | |
| Aarhus University Hospital, Skejby | Recruiting |
| Aarhus, Aarhus N, Denmark, 8200 | |
| Contact: Nikolaj Eldrup eldrup@clin.au.dk | |
| Sub-Investigator: Nikolaj Eldrup, MD, PHD | |
| Aalborg Hospital | Not yet recruiting |
| Aalborg, Denmark, 9000 | |
| Contact: Troels F Pedersen, MD troels.fogh@ki.au.dk | |
| Principal Investigator: Troels F Pedersen, MD | |
Sponsors and Collaborators
Aarhus University Hospital
More Information
| Responsible Party: | Nikolaj Eldrup, MD, PHD, Aarhus University Hospital |
| ClinicalTrials.gov Identifier: | NCT01523262 History of Changes |
| Other Study ID Numbers: | M-20100012 |
| Study First Received: | January 30, 2012 |
| Last Updated: | January 12, 2015 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Aarhus University Hospital:
|
preconditioning aortic aneurysm |
Additional relevant MeSH terms:
|
Ischemia Aneurysm Aortic Aneurysm Myocardial Ischemia Coronary Artery Disease Aortic Aneurysm, Abdominal Pathologic Processes |
Vascular Diseases Cardiovascular Diseases Aortic Diseases Heart Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on September 26, 2016