Phase 2
Completed N=205
Remote Ischemic Preconditioning Prior to Vascular Surgery
Peripheral arterial disease · Vascular Surgery
Source: ClinicalTrials.gov NCT01558596 ↗
Enrolled (actual)
205
Serious AEs
6.5%
Results posted
Dec 2016
Primary outcomePrimary: Troponin I Elevation Above the Upper Reference Limit (URL) — 25; 22 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Troponin I Elevation Above the Upper Reference Limit (URL) |
25; 22 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01558596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.