Remote Ischemic Preconditioning Prior to Vascular Surgery (CRIPES)

• ClinicalTrials.gov Identifier: NCT01558596
• Recruitment Status: Completed
• First Posted: March 20, 2012
• Results First Posted: December 6, 2016
• Last Update Posted: March 22, 2017
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease; Vascular Surgery	Procedure: Preconditioning; Procedure: Control	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
• Study Start Date: September 2011
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Sham; Blood pressure cuff inflated to 40-50 mmHg in the upper extremity	Procedure: Control; Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
Experimental: RIPC; 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: 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.

Outcome Measures

Primary Outcome Measures :

1. Troponin I Elevation Above the Upper Reference Limit (URL) [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Santiago A Garcia, MD; Minneapolis VA Health Care System, Minneapolis, MN

More Information

Publications of Results:

Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01558596
• Other Study ID Numbers: CLIN-014-11F
• First Posted: March 20, 2012
• Results First Posted: December 6, 2016
• Last Update Posted: March 22, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases