Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Transplantation
Intervention: Bradykinin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
James A S AS Muldowney, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
James Muldowney, III, MD, Phone: 615-936-1720, Email: james.muldowney@vanderbilt.edu
Summary
Heart transplant recipients do not have nerves to their hearts. This protocol tests the
hypothesis that bradykinin mediated t-PA release in the coronary arteries will be reduced in
heart transplant recipients compared to healthy subjects.
This study will compare heart transplant recipients to healthy controls who are undergoing
cardiac cath for standard of care purposes (separate protocol) and compare the coronary
arteries to the forearm in transplant recipients (separate protocol) and healthy controls
(separate protocol).
Clinical Details
Official title: The Effects of Cardiac Innervation on Intra-Coronary t-PA Release
Study design: Basic Science, Open Label, Single Group Assignment
Primary outcome: T-PA release in the coronary artery bed.
Secondary outcome: Heart rate variabilityHistopathology for arteriolar t-PA and sympathetic neurons
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. Heart transplant recipients undergoing annual cardiac catheterization who have
participated our protocol: 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). (IRB # 070517)
2. 25 Subjects will have transplant vasculopathy and 25 subjects will be free of
transplant vasculopathy, as documented in previous angiograms.
3. Otherwise 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
Healthy controls are being enrolled in SCCOR Project 1, Aims 3A and 3B (IRB# 030473 and
061160) and will not be participating under this IRB number.
Locations and Contacts
James Muldowney, III, MD, Phone: 615-936-1720, Email: james.muldowney@vanderbilt.edu
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
James AS Muldowney, III, MD, Phone: 615-936-1720, Email: james.muldowney@vanderbilt.edu
Tami Neal, RN, Phone: 615-936-1931, Email: tami.neal@vanderbilt.edu
Additional Information
Starting date: October 2008
Ending date: May 2011
Last updated: June 24, 2009
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