Remote Ischemic Preconditioning Prior to Vascular Surgery
This trial is active, not recruiting.
|Conditions||peripheral arterial disease, vascular surgery|
|Phase||phase 1/phase 2|
|Sponsor||VA Office of Research and Development|
|Start date||September 2011|
|End date||December 2015|
|Trial size||180 participants|
|Trial identifier||NCT01558596, CLIN-014-11F|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Troponin I elevation above the URL
time frame: Within 3 days of the vascular operation
Male or female participants from 18 years up to 99 years old.
Inclusion Criteria: - 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. 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
|Official title||Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery|
|Principal investigator||Santiago A Garcia, MD|
|Description||The proposed investigation has a single blind, randomized design and plans to enroll 180 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.|
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