Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients
Withdrawn before enrolling · Not applicable
Conditions studied: Heart Transplantation
In brief
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).
Key facts
- Study ID
- NCT00780377
- Run by
- Vanderbilt University
- People needed
- 0
- Starts
- 2008-10-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2017-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- 25 Subjects will have transplant vasculopathy and 25 subjects will be free of transplant vasculopathy, as documented in previous angiograms.
- Otherwise healthy
You may not qualify if…
- PVC < 30
- Hypertensive subjects on ACE inhibitors
- Pregnant or nursing mothers
- Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
- Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
- Triglycerides > 200
- Previously diagnosed obstructive coronary artery disease
- Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
- History of cerebrovascular disease
- Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
- 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).
- Angiotensin converting enzyme inhibitor use
- Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
- Peripheral Vascular Disease
- 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.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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