Endothelial Function and Vein Graft Remodeling - Full Text View

Endothelial Function and Vein Graft Remodeling (EFVGR)

This study is currently recruiting participants.

Verified by University of California, San Francisco, January 2009

First Received: January 27, 2009 No Changes Posted

Sponsors and Collaborators:	University of California, San Francisco National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00831090

Purpose

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.

Condition
Peripheral Arterial Disease Cardiovascular Disease

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Endothelial Function and Vein Graft Remodeling

Further study details as provided by University of California, San Francisco:

Study Start Date:

January 2009

Eligibility

Ages Eligible for Study:	22 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Vascular Surgery clinic

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831090

Contacts

Contact: Diana Kim, M.P.H.

415-353-4366

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States
San Francisco Veterans Affairs Medical Center	Recruiting
San Francisco, California, United States

Sponsors and Collaborators

University of California, San Francisco

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Christopher D. Owens, M.D., M.P.H.

University of California, San Francisco

More Information

No publications provided

Responsible Party:	University of California, San Francisco ( Christopher D. Owens, M.D. )
Study ID Numbers:	H63794-33476, HL 92163-01
Study First Received:	January 27, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00831090 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 03, 2009