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Endothelial Function and Vein Graft Remodeling (EFVGR)

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00831090
First received: January 27, 2009
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endothelial Function and Vein Graft Remodeling

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Successful early vein graft remodeling [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    An increase in vein graft lumen diameter at three months


Biospecimen Retention:   Samples Without DNA

A segment of vein that would usually be discarded will be taken to a lab for testing of endothelial reactivity and quantification of endothelial coverage through CD31 staining.


Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  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
ClinicalTrials.gov Identifier: NCT00831090     History of Changes
Other Study ID Numbers: 10-02338, HL 92163-01
Study First Received: January 27, 2009
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013