Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients (P1A4D)
|ClinicalTrials.gov Identifier: NCT00780377|
Recruitment Status : Withdrawn (Unable to perform study due to unavailable drug, then unable to partner with cath lab)
First Posted : October 27, 2008
Last Update Posted : March 20, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplantation||Drug: Bradykinin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Cardiac Innervation on Intra-coronary t-PA Release|
|Actual Study Start Date :||October 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||May 2011|
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.
Bradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose.
- T-PA release in the coronary artery bed. [ Time Frame: Single Study Visit ]
- Heart rate variability [ Time Frame: Single study visit ]
- Histopathology for arteriolar t-PA and sympathetic neurons [ Time Frame: Single Study Visit ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780377
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||James A S AS Muldowney, MD||Vanderbilt University Medical Center|