Remote Ischemic Preconditioning Prior to Vascular Surgery

Peripheral Arterial Disease Clinical Trial

— CRIPES  

Official title:

Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01558596
• Other study ID #: CLIN-014-11F
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: March 16, 2012
• Last updated: June 23, 2016
• Start date: September 2011
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin I elevation above the URL	Troponin I is biomarker of myocardial necrosis	Within 3 days of the vascular operation	No