Remote Ischemic Preconditioning Prior to Vascular Surgery

Phase 1

Completed

• Conditions: Vascular Surgery; Peripheral Arterial Disease
• Interventions: Procedure: Preconditioning; Procedure: Control

• Registration Number: NCT01558596
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description

The proposed investigation has a single blind, randomized design and plans to enroll 180-205 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-20
• Primary Completion: 2015-12
• Study Completion: 2016-09
• Results First Submitted: 2016-10-12
• Results First Submitted QC: 2016-10-12
• Results First Posted: 2016-12-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC	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.
Sham	Control	Blood pressure cuff inflated to 40-50 mmHg in the upper extremity

Primary Outcome Measures

Name	Time	Method
Troponin I Elevation Above the Upper Reference Limit (URL)	Within 3 days of the vascular operation	Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period

Trial Locations

Locations (1)

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States