Brachial Artery t-PA Release in Heart Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. This is because heart transplant recipients do not have nerves to their coronary arteries.

This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant recipients. The brachial artery has intact nerves.

Separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tissue-Type Plasminogen Activator (t-PA) Release Predicts Major Adverse Cardiac Events (MACE) in Patients With Non-critical Coronary Artery Disease

NCT00868855

Coronary Artery Disease

TERMINATED PHASE1

Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden

NCT06769256

ST-segment Elevation Myocardial Infarction (STEMI)

RECRUITING PHASE4

The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway

NCT00965393

Ischaemic Heart Diseases

COMPLETED NA

The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway

NCT00965120

Ischaemic Heart Diseases

COMPLETED NA

A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI

NCT03236311

Microvascular Coronary Artery Disease

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bradykinin

Patients receive 0, 10, 20, and 40 ng/min/100cc forearm volume of intrabrachial bradykinin, for 5 minutes at each dose. Forearm blood flow will be measured by strain gauge plethysmography, blood samples will be obtained to measure t-PA, PAI-1 at each dose. FMD and Radial artery tonometry will also be performed under resting conditions.

Group Type EXPERIMENTAL

Bradykinin

Intervention Type DRUG

Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bradykinin

Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adults 18 years and greater who have undergone heart transplantation
2. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No