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Trial record 4 of 139 for:    Peripheral Arterial Disease OR claudication OR peripheral vascular disease | Open Studies | NIH, U.S. Fed
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Remote Ischemic Preconditioning Prior to Vascular Surgery (CRIPES)

This study is currently recruiting participants.
Verified January 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01558596
First received: March 16, 2012
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

We 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Troponin I elevation above the URL [ Time Frame: Within 3 days of the vascular operation ] [ Designated as safety issue: No ]
    Troponin I is biomarker of myocardial necrosis


Estimated Enrollment: 180
Study Start Date: September 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
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
Other Name: Control
Experimental: Arm 2
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 patients who are scheduled to have major, elective vascular surgery for occlusive carotid disease, expanding 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, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia.
  2. Age > 18.
  3. Provides informed consent.

Exclusion Criteria:

  1. Hypertensive crisis
  2. Peripheral arterial disease of the upper extremities
  3. AV fistula
  4. ACS in the last 6 months
  5. Severe valvular heart disease
  6. Pregnant women
  7. Unable to provide consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558596

Contacts
Contact: Santiago A Garcia, MD (612) 725-2000 ext 3662 Santiago.Garcia@va.gov

Locations
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Santiago A Garcia, MD     612-725-2000 ext 3662     Santiago.Garcia@va.gov    
Principal Investigator: Santiago A. Garcia, MD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Santiago A. Garcia, MD Minneapolis VA Health Care System, Minneapolis, MN
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01558596     History of Changes
Other Study ID Numbers: CLIN-014-11F
Study First Received: March 16, 2012
Last Updated: January 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013