Overview

This trial is active, not recruiting.

Conditions peripheral arterial disease, vascular surgery
Treatments preconditioning, control
Phase phase 1/phase 2
Sponsor VA Office of Research and Development
Start date September 2011
End date December 2015
Trial size 180 participants
Trial identifier NCT01558596, CLIN-014-11F

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Placebo Comparator)
Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
control
Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
(Experimental)
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.
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.

Primary Outcomes

Measure
Troponin I elevation above the URL
time frame: Within 3 days of the vascular operation

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

Official title Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
Principal investigator Santiago A Garcia, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.