Cardiovascular Disease Clinical Trial
— EFVGROfficial title:
Endothelial Function and Vein Graft Remodeling
Verified date | September 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to better understand why some vein bypass grafts develop narrowing. Evidence suggests that there is a relationship between inflammatory markers in the blood and the narrowing that occurs in blood vessels. In this study, we will look at inflammatory markers in the blood and how well the vein graft functions.
Status | Completed |
Enrollment | 55 |
Est. completion date | January 16, 2015 |
Est. primary completion date | January 16, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 89 Years |
Eligibility | Inclusion Criteria: - Age > 22 or < 90 years - Undergoing lower extremity (infrainguinal) bypass using autologous vein for the treatment of disabling claudication or critical limb ischemia secondary to chronic atherosclerotic occlusive disease - Able to understand, give, and take part in the consent process Exclusion Criteria: - Age < 22 or > 90 years - Grafts employing prosthetic or other non-autologous vein material in any part (e.g. composite grafts). [Patch angioplasty of inflow and outflow vessel permissible with any material] - Vasculitis, trauma, acute embolic disease as etiology of limb ischemia - History of diagnosed hypercoagulable state - Evidence of active infection - pneumonia, urinary tract, etc., requiring medical therapy - Evidence of significant local sepsis in foot or limb prior to bypass - Patients taking immunosuppressant medications (steroids, chemotherapeutic agents) - Other concurrent significant illness within 30 days - Non-English speakers |
Country | Name | City | State |
---|---|---|---|
United States | San Francisco Veterans Affairs Medical Center | San Francisco | California |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful early vein graft remodeling | An increase in vein graft lumen diameter at three months | 3 Months |
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