Brachial Artery t-PA Release in Heart Transplant Recipients
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Transplantation
Intervention: Bradykinin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
James AS Muldowney, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
James AS Muldowney, III, MD, Phone: 615-936-1720, Email: james.muldowney@vanderbilt.edu
Summary
Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in
culture. It has been proposed that the nerves of blood vessels are the source of bradykinin
stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin
into the brachial (arm) artery and the coronary arteries of heart transplant recipients and
control subjects. This is because heart transplant recipients do not have nerves to their
coronary arteries.
This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant
recipients. The brachial artery has intact nerves.
Separate protocols address coronary artery infusions in healthy subjects and transplant
recipients and forearm infusions in healthy subjects.
Clinical Details
Official title: Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures in Heart Transplant Recipients (SCCOR Project 1, Aim 3C)
Study design: Basic Science, Non-Randomized, Open Label, Single Group Assignment
Primary outcome: Peak t-PA release
Secondary outcome: t-PA release at various doses
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. Adults 18 years and greater who have undergone heart transplantation
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
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 ≥ 150% of control)
14. Peripheral Vascular Disease
15. Other chronic medical illnesses at the discretion of the investigators
Locations and Contacts
James AS Muldowney, III, MD, Phone: 615-936-1720, Email: james.muldowney@vanderbilt.edu
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States
Additional Information
Starting date: October 2008
Ending date: May 2011
Last updated: October 24, 2008
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