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Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation (P1A3B)

This study has been terminated.
(Lack of enrollment due to strict inclusion/exclusion criteria. Bradykinin shortage)
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University Identifier:
First received: October 24, 2008
Last updated: July 14, 2016
Last verified: July 2016
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.

Condition Intervention
Drug: Bradykinin

Vanderbilt University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
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)

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Peak t-PA release [ Time Frame: Single Study day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: January 2007
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bradykinin
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.
Drug: Bradykinin
Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  1. Adults 18 years and greater
  2. Healthy

Exclusion criteria:

  1. PVC < 30
  2. Hypertensive subjects on ACE inhibitors
  3. Pregnant or nursing mothers
  4. Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
  5. Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
  6. Triglycerides > 200
  7. Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure)
  8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
  9. History of cerebrovascular disease
  10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
  11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
  12. Angiotensin converting enzyme inhibitor use
  13. Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control)
  14. Other chronic medical illnesses at the discretion of the investigators
  Contacts and Locations
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Please refer to this study by its identifier: NCT00780481

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: James AS Muldowney, MD Vanderbilt University
  More Information

Responsible Party: James Muldowney, Assistant Professor of Medicine, Vanderbilt University Identifier: NCT00780481     History of Changes
Other Study ID Numbers: 061160 
Study First Received: October 24, 2008
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Endothelial Function
Fibrinolytic Balance

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Pathologic Processes
Vasodilator Agents
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016