We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endothelial Function in Lower Extremity Bypass Grafts

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00759707
First Posted: September 25, 2008
Last Update Posted: May 16, 2017
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.
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital
Results First Submitted: December 8, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Peripheral Arterial Disease
Intervention: Drug: L-N^G monomethyl arginine (L-NMMA)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Study Population All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.

Participant Flow:   Overall Study
    Study Population
STARTED   19 
COMPLETED   19 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Study Population All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.

Baseline Measures
   Study Population 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  26.3% 
Male      14  73.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   5.3% 
White      16  84.2% 
More than one race      0   0.0% 
Unknown or Not Reported      2  10.5% 
Region of Enrollment 
[Units: Participants]
 
United States   19 


  Outcome Measures

1.  Primary:   Change From Baseline in Saphenous Vein Bypass Graft Vasodilation   [ Time Frame: Single visit study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Joshua Beckman
Organization: Brigham and Women's Hospital
phone: 6175257053
e-mail: jbeckman@partners.org



Responsible Party: Joshua A. Beckman, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00759707     History of Changes
Other Study ID Numbers: 2006P-000424
First Submitted: September 24, 2008
First Posted: September 25, 2008
Results First Submitted: December 8, 2016
Results First Posted: April 6, 2017
Last Update Posted: May 16, 2017