Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients

Heart Transplantation Clinical Trial

— P1A4D  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00780377
• Other study ID #: 080823
• Status: Withdrawn
• Phase: N/A
• First received: October 24, 2008
• Last updated: March 16, 2017
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-PA release in the coronary artery bed.		Single Study Visit
Secondary	Heart rate variability		Single study visit
Secondary	Histopathology for arteriolar t-PA and sympathetic neurons		Single Study Visit