Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- VA Office of Research and Development
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Troponin I Elevation Above the Upper Reference Limit (URL)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia.
- •Provides informed consent.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Troponin I Elevation Above the Upper Reference Limit (URL)
Time Frame: 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