Remote Ischemic Preconditioning Prior to Vascular Surgery (CRIPES)

VA Office of Research and Development

Status and phase: Completed; Phase 2; Phase 1

Conditions: Vascular Surgery; Peripheral Arterial Disease

Treatments: Procedure: Preconditioning; Procedure: Control

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01558596

CLIN-014-11F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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201 participants in 2 patient groups, including a placebo group

Sham

Placebo Comparator group

Description:

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

Treatment:

Procedure: Control

RIPC

Experimental group

Description:

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.

Treatment:

Procedure: Preconditioning