Phase 2
N=205
Remote Ischemic Preconditioning Prior to Vascular Surgery
Peripheral Arterial Disease · Vascular Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01558596 ↗Enrolled (actual)
205
Serious AEs
6.5%
Results posted
Dec 2016
Primary outcome: Primary: Troponin I Elevation Above the Upper Reference Limit (URL) — 25; 22 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Preconditioning (Procedure); Control (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Troponin I Elevation Above the Upper Reference Limit (URL) |
25; 22 | — |
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.
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.