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Remote Ischemic Preconditioning Prior to Vascular Surgery

NCT01558596 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2017-03-22

Study results available
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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.

Conditions

  • Peripheral Arterial Disease
  • Vascular Surgery

Interventions

PROCEDURE

Preconditioning

Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.

PROCEDURE

Control

Blood pressure cuff inflated to 40-50 mmHg in the upper extremity

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Santiago A Garcia, MD · Minneapolis VA Health Care System, Minneapolis, MN

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-12-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01558596 on ClinicalTrials.gov