Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery

Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. This study is testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: No
View:

• Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia.

• Age > 18.

• Provides informed consent.

Locations
United States
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis
Time Frame
Start Date: September 2011
Completion Date: September 2016
Participants
Target number of participants: 201
Treatments
Placebo Comparator: Sham
Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
Experimental: RIPC
Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov

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