Expired Study
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Nashville, Tennessee 37232


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

070517


NCT ID:

NCT00780637


Secondary ID:


Study Acronym:

P1A3C


Brief Title:

Brachial Artery t-PA Release in Heart Transplant Recipients


Official Title:

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)


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Bradykinin Shortage, SCCOR expired prior to


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model: Si


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:James AS Muldowney, MD
Principal Investigator
Vanderbilt University

Study Dates

Start Date:October 2008
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:January 2011
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 14, 2016
First Received Date:October 24, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Peak t-PA release
Time Frame:Single Study Visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:t-PA release at various doses
Time Frame:Single Study Visit
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Bradykinin
Description:Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.
Arm Name:Bradykinin

Study Arms

Study Arm Type:Experimental
Arm Name:Bradykinin
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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