Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:October 2008
End Date:May 2011
Contact:James Muldowney, III, MD
Email:james.muldowney@vanderbilt.edu
Phone:615-936-1720

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The Effects of Cardiac Innervation on Intra-Coronary t-PA Release

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).


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.
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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