Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation (P1A3B)
Recruitment status was Recruiting
T-PA release is impaired in obese subjects. In order to have a better mechanistic understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.
Vanderbilt University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures (SCCOR Project 1 Aim 3B)|
- Peak t-PA release [ Time Frame: Single Study day ] [ Designated as safety issue: No ]
- Peak FMD [ Time Frame: Single Study Day ] [ Designated as safety issue: No ]
- Radial Artery Elasticity [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]
- Lipid levels, PAI-1 levels, CRP levels, F2 Isoprostanes and other biomarkers of inflammation and obesity. [ Time Frame: Single Study Day ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780481
|Contact: James AS Muldowney, III, MDfirstname.lastname@example.org|
|Contact: Tami Neal, RNemail@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: James AS Muldowney, III, MD 615-936-1750 firstname.lastname@example.org|
|Contact: Tami Neal 615-936-1931 email@example.com|
|Sub-Investigator: Douglas Vaughan, MD|
|Sub-Investigator: Robert N Piana, MD|
|Principal Investigator:||James AS Muldowney, MD||Vanderbilt University|