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Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery (CRIPES)

This study is currently recruiting participants.
Verified July 2011 by Minnesota Veterans Research Institute
Sponsor:
Information provided by:
Minnesota Veterans Research Institute
ClinicalTrials.gov Identifier:
NCT01403337
First received: July 26, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

Vascular surgery is considered a high-risk operation with an anticipated risk of major cardiovascular complications in excess of 5%. The occurrence of a cardiovascular complication after surgery carries a long-term higher mortality risk. The main objective of this investigation is to reduce the proportion of patients having major cardiovascular complications during surgery through a clinical protocol of remote preconditioning that is safe, effective and reproducible.


Condition Intervention Phase
Peripheral Arterial Disease
 Other: Ischemic preconditioning
Other: Control
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery (CRIPES)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Minnesota Veterans Research Institute:

Primary Outcome Measures:
  • Troponin I elevation above the URL [ Time Frame: Within 1 week after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Blood pressure cuff inflated in the right or left arm to 40-50 mmHg
 Other: Control
A Blood Pressure cuff inflated to 40-50 mmHg
Active Comparator: Preconditioning
The RIPC protocol will consist of three cycles of the following: 5-minute inflation of a blood pressure cuff around the right upper arm to 200 mmHg (or 20 above the systolic blood pressure if baseline BP > 200 mmHg) to allow for external compression of the brachial artery resulting in transient arm ischemia, followed by a 5-minute interval of cuff deflation to allow for reperfusion. The total duration of the protocol is 30 minutes equally divided between ischemia and reperfusion. The protocol is to be applied in the patient room the morning of the operation.
 Other: Ischemic preconditioning
The RIPC protocol will consist of three cycles of the following: 5-minute inflation of a blood pressure cuff around the right upper arm to 200 mmHg (or 20 above the systolic blood pressure if baseline BP > 200 mmHg) to allow for external compression of the brachial artery resulting in transient arm ischemia, followed by a 5-minute interval of cuff deflation to allow for reperfusion. The total duration of the protocol is 30 minutes equally divided between ischemia and reperfusion. The protocol is to be applied in the patient room the morning of the operation.

  Eligibility

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

Inclusion Criteria:

  • Eligible patients would be those undergoing elective major vascular surgery at the Minneapolis VA Medical Center for an expanding abdominal aortic aneurysm, obstructive carotid disease, and/or chronic limb ischemia during the study period. All patients must be ≥ 18 years of age and provide written informed consent.

Exclusion Criteria:

  • Exclusion criteria include hypertensive crisis, acute coronary syndrome in the preceding 6 weeks, severe valvular heart disease, peripheral arterial disease of the upper extremities, manifested by a systolic blood pressure difference greater than 20 mmHg, pregnant women, patients unable to understand the consent process due to mental illness, advanced malignancy with limited life expectancy (<1 year), and hemodialysis with a fistula in the upper extremity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403337

Contacts
Contact: Stacy McNabb, RN 6124675977 Stacy.McNabb@va.gov

Locations
United States, Minnesota
Minneapolis VA Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Stacy McNabb, RN     612-467-5977     Stacy.McNabb@va.gov    
Principal Investigator: Santiago Garcia, MD            
Sponsors and Collaborators
Minnesota Veterans Research Institute
Investigators
Principal Investigator: Santiago A Garcia, MD Minneapolis VA Medical Center and The University of Minnesota
  More Information

No publications provided

Responsible Party: Santiago Garcia, MD, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier: NCT01403337     History of Changes
Other Study ID Numbers: 411652941
Study First Received: July 26, 2011
Last Updated: July 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Minnesota Veterans Research Institute:
peripheral arterial disease
myocardial infarction

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 June 18, 2013