Remote Ischemic Preconditioning Prior to Vascular Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | September 2016 |
Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
