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Endothelial Function and Vein Graft Remodeling (EFVGR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00831090
Recruitment Status : Unknown
Verified April 2016 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : January 28, 2009
Last Update Posted : April 5, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date January 27, 2009
First Posted Date January 28, 2009
Last Update Posted Date April 5, 2016
Study Start Date January 2009
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2013)
Successful early vein graft remodeling [ Time Frame: 3 Months ]
An increase in vein graft lumen diameter at three months
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endothelial Function and Vein Graft Remodeling
Official Title Endothelial Function and Vein Graft Remodeling
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Vascular Surgery clinic
Condition
  • Peripheral Arterial Disease
  • Cardiovascular Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 21, 2013)
60
Original Enrollment Not Provided
Estimated Study Completion Date December 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00831090
Other Study ID Numbers 10-02338
HL 92163-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Christopher D. Owens, M.D., M.P.H. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date April 2016