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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00780377 |
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 | Intervention |
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Heart Transplantation |
Drug: Bradykinin |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment |
Official Title: | The Effects of Cardiac Innervation on Intra-Coronary t-PA Release |
Estimated Enrollment: | 100 |
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) |
Arms | Assigned Interventions |
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Bradykinin: Experimental
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.
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Drug: Bradykinin
Bradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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.
Contact: James Muldowney, III, MD | 615-936-1720 | james.muldowney@vanderbilt.edu |
Contact: tami neal, RN | 615-936-1931 | tami.neal@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: James AS Muldowney, III, MD 615-936-1720 james.muldowney@vanderbilt.edu | |
Contact: Tami Neal, RN 615-936-1931 tami.neal@vanderbilt.edu |
Principal Investigator: | James A S AS Muldowney, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University School of Medicine ( James Muldowney, M.D., F.A.C.C., Assistant Professor of Medicine ) |
Study ID Numbers: | 080823 |
Study First Received: | October 24, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00780377 |
Health Authority: | United States: Food and Drug Administration |
Heart Transplant Fibrinolysis Resting conditions |
Bradykinin Tissue Plasminogen Activator |
Vasodilator Agents Therapeutic Uses Cardiovascular Agents Pharmacologic Actions |