Endothelial Function and Vein Graft Remodeling

Cardiovascular Disease Clinical Trial

— EFVGR  

Official title:

Endothelial Function and Vein Graft Remodeling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831090
• Other study ID #: 10-02338
• Secondary ID: HL92163-01
• Status: Completed
• Start date: January 2009
• Est. completion date: January 16, 2015

Study information

• Verified date: September 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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