Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00780377

Acronym

P1A4D

Enrollment

Registered

2008-10-27

Start date

2008-10-31

Completion date

2011-05-31

Last updated

2017-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

Keywords

Heart Transplant, Fibrinolysis, Resting conditions

Brief 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).

Interventions

DRUGBradykinin

Bradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
T-PA release in the coronary artery bed.	Single Study Visit

Secondary

Measure	Time frame
Heart rate variability	Single study visit
Histopathology for arteriolar t-PA and sympathetic neurons	Single Study Visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026