Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients (P1A4D)
Recruitment status was: Recruiting
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).
Vanderbilt University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||The Effects of Cardiac Innervation on Intra-Coronary t-PA Release|
- T-PA release in the coronary artery bed. [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]
- Heart rate variability [ Time Frame: Single study visit ] [ Designated as safety issue: No ]
- Histopathology for arteriolar t-PA and sympathetic neurons [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780377
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||James A S AS Muldowney, MD||Vanderbilt University|