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NCT01523262 Clinical Trial

Preventing Myocardial Ischemia by Preconditioning in Elective Operation for Abdominal Aortic Aneurysm

Aortic Aneurysm Clinical Trial

Official title:
The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01523262
Other study ID # M-20100012
Secondary ID
Status Recruiting
Phase Phase 1
First received January 30, 2012
Last updated January 12, 2015
Start date January 2011
Est. completion date January 2016

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 2016
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• preconditioning
peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm
• Normal surgery, with sham intervention without inflating arm cuff

Locations
Country Name City State
Denmark Aalborg Hospital Aalborg
Denmark Aarhus University Hospital, Skejby Aarhus Aarhus N

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary measurements of CKMB and Troponin T 30 days No
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