Remote Ischemic Preconditioning Prior to Vascular Surgery — CRIPES  

Peripheral Arterial Disease Clinical Trial

Official title: Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Surgery

• NCT number: NCT01558596
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2011
• Completion date: September 2016