NCT01403337
Completed
Phase 1
Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery (CRIPES)
ConditionsPeripheral Arterial Disease
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.
Investigators
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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