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Remote Ischemic Preconditioning Prior to Vascular Surgery (CRIPES)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558596
First Posted: March 20, 2012
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention Phase
Peripheral Arterial Disease Vascular Surgery Procedure: Preconditioning Procedure: Control Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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


Enrollment: 201
Study Start Date: September 2011
Study Completion Date: September 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558596


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:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01558596     History of Changes
Other Study ID Numbers: CLIN-014-11F
First Submitted: March 16, 2012
First Posted: March 20, 2012
Results First Submitted: October 12, 2016
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