Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients

NCT ID: NCT00780377

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-05-31

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).

Conditions

Heart Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Bradykinin

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.

Group Type: EXPERIMENTAL

Bradykinin

Intervention Type: DRUG

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

Interventions

Bradykinin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

James Muldowney

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James A S AS Muldowney, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

080823

Identifier Type: -

Identifier Source: org_study_id