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Clinical Trials/NCT01403337
NCT01403337
Completed
Phase 1

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

Center for Veterans Research and Education1 site in 1 country205 target enrollmentJuly 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Center for Veterans Research and Education
Enrollment
205
Locations
1
Primary Endpoint
Troponin I elevation above the URL
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Santiago Garcia

Staff Cardiologist

Minneapolis Veterans Affairs Medical Center

Eligibility 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.

Outcomes

Primary Outcomes

Troponin I elevation above the URL

Time Frame: Within 1 week after surgery

Study Sites (1)

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