Remote Ischemic Preconditioning Prior to Vascular Surgery
- Conditions
- Vascular SurgeryPeripheral Arterial Disease
- Registration Number
- NCT01558596
- Lead Sponsor
- VA Office of Research and Development
- Brief 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.
- Detailed Description
The proposed investigation has a single blind, randomized design and plans to enroll 180-205 patients who are scheduled to have major, elective vascular surgery for occlusive carotid disease, expanding abdominal aortic aneurysm (AAA), occlusive lower extremity disease and/or critical limb ischemia at the Minneapolis VA Health Care Center. 24 hours prior to the patient's scheduled vascular operation, RIPC therapy will be applied to one of the participant's upper arms to cause forearm ischemia. Clinically collected, pre-operative troponins, creatine kinase MBs (CK-MBs), EKGs along with troponins, CK-MBs and EKGs collected on day 1, 2, 3 and day 7 (if still hospitalized) will be utilized to evaluate the occurrence of perioperative, adverse cardiac events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- 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.
- Hypertensive crisis
- Peripheral arterial disease of the upper extremities
- Arteriovenous (AV) fistula
- Acute Coronary Syndrome (ACS) in the last 6 months
- Severe valvular heart disease
- Pregnant women
- Unable to provide consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Troponin I Elevation Above the Upper Reference Limit (URL) Within 3 days of the vascular operation Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Minneapolis VA Health Care System, Minneapolis, MN
🇺🇸Minneapolis, Minnesota, United States
Minneapolis VA Health Care System, Minneapolis, MN🇺🇸Minneapolis, Minnesota, United States