Peripheral Arterial Disease Clinical Trial
— CRIPESOfficial title:
Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
Verified date | June 2016 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | September 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Troponin I elevation above the URL | Troponin I is biomarker of myocardial necrosis | Within 3 days of the vascular operation | No |
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