- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00831090
Endothelial Function and Vein Graft Remodeling (EFVGR)
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Despite the acceptance of catheter-based approaches to lower extremity reconstruction, bypass with autogenous vein remains the most durable option. In the United States alone there are approximately 100,000 lower extremity bypass procedures performed yearly. However, 30-50% of these grafts either occlude or require revision in the first 5 years.
Traditional Framingham cardiovascular risk factors such as dyslipidemia and diabetes do not predict which grafts are at risk for failure. Therefore other variables such as hemodynamic factors or endothelial function may be important in identifying vulnerable vein grafts. The applicant has previously noted that vein grafts undergo dramatic geometric remodeling within the first month after implantation into the arterial circulation. This is partly driven by hemodynamic forces such as shear stress and is thought to be related to endothelial function. Shear stress is positively correlated with early (0-1 month) luminal enlargement. This adaptive response is important to maintain bypass graft patency. However, there is considerable amount of variability in this response unaccounted for by shear stress alone. The applicant has further shown that baseline systemic inflammation dampens the ability for adequate vein graft luminal expansion and therefore may uncouple the mechano-chemical signal transduction at the endothelial level. Therefore, this study will examine the relationship between circulating levels of inflammatory mediators and endothelial function in a cohort of patients undergoing lower extremity arterial reconstruction with autogenous vein.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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California
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San Francisco, California, Verenigde Staten, 94143
- University of California, San Francisco
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San Francisco, California, Verenigde Staten, 94121
- San Francisco Veterans Affairs Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Successful early vein graft remodeling
Tijdsspanne: 3 Months
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An increase in vein graft lumen diameter at three months
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3 Months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Warren J. Gasper, M.D., University of California, San Francisco
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 10-02338
- HL92163-01
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