Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients (P1A4D)
This study has been withdrawn prior to enrollment.
(Unable to perform study due to unavailable drug, then unable to partner with cath lab)
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University Medical Center
First received: October 24, 2008
Last updated: March 16, 2017
Last verified: March 2017
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).
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Basic Science
||The Effects of Cardiac Innervation on Intra-coronary t-PA Release
Primary Outcome Measures:
- T-PA release in the coronary artery bed. [ Time Frame: Single Study Visit ]
Secondary Outcome Measures:
- Heart rate variability [ Time Frame: Single study visit ]
- Histopathology for arteriolar t-PA and sympathetic neurons [ Time Frame: Single Study Visit ]
| Actual Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
Patients have holter monitoring. Patients receive intracoronary bradykinin (0.2, 0.6, 2.0 ug/min) and have coronary sinus and coronary artery blood sampling for t-PA and O2 content.
Bradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00780377
|Vanderbilt University Medical Center
|Nashville, Tennessee, United States, 37232 |
||James A S AS Muldowney, MD
||Vanderbilt University Medical Center
||James Muldowney, Assistant Professor, Vanderbilt University Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 24, 2008
||March 16, 2017
Keywords provided by Vanderbilt University Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 28, 2017
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