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Remote Ischemic Preconditioning Prior to Vascular Surgery (CRIPES)

Primary Purpose

Peripheral Arterial Disease, Vascular Surgery

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Preconditioning
Control
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Minneapolis VA Health Care System, Minneapolis, MN

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sham

RIPC

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Troponin I Elevation Above the Upper Reference Limit (URL)
Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period

Secondary Outcome Measures

Full Information

First Posted
March 16, 2012
Last Updated
February 1, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01558596
Brief Title
Remote Ischemic Preconditioning Prior to Vascular Surgery
Acronym
CRIPES
Official Title
Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Vascular Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Placebo Comparator
Arm Description
Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
Arm Title
RIPC
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Preconditioning
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
Primary Outcome Measure Information:
Title
Troponin I Elevation Above the Upper Reference Limit (URL)
Description
Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period
Time Frame
Within 3 days of the vascular operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago A Garcia, MD
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27688236
Citation
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.
Results Reference
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Remote Ischemic Preconditioning Prior to Vascular Surgery

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