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Sponsors and Collaborators: |
University Hospital Inselspital, Berne Swiss National Science Foundation Swiss Heart Foundation |
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Information provided by: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT00414895 |
The goal of this study is to detect AR and CR in the transplanted heart by quantitative assessment of myocardial blood flow and its constituents by myocardial contrast echocardiography (MCE). Further we investigate the collateral circulation in these patients.
Condition |
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Cardiac Transplantation |
Study Type: | Observational |
Study Design: | Longitudinal, Defined Population, Prospective Study |
Official Title: | Absolute Myocardial Perfusion Measurement in the Transplanted Heart: a New Method for Accurate Detection of Allograft Rejection. A Pilot Study |
Estimated Enrollment: | 90 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2008 |
Heart transplantation has become an accepted therapy for end-stage heart failure. Acute allograft rejection (AR) remains a major cause of mortality in heart transplant recipients. Chronic rejection (CR) determines the long-term prognosis after cardiac transplantation and is responsible for more than one third of late deaths. Different non-invasive methods have been evaluated for the detection of AR, but the gold standard remains endomyocardial biopsy (EMB).
Very little is known about the impact of CR on the collateral circulation in transplant patients. Since the collateral circulation of the heart is mainly part of the microcirculation, it can be hypothesized that it is less developed than in “normal” coronary atherosclerosis without microvascular lesions.
The quantification of CR with non-invasive techniques has remained difficult. In this context, there is a need for a reliable non-invasive test to avoid regularly invasive evaluation.
Based on the above considerations we propose that both AR and CR can be accurately detected and differentiated using non-invasive quantitative myocardial contrast echocardiography (MCE).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tobias Rutz, MD | +41 6321 12 77 | tobias.rutz@insel.ch |
Switzerland | |
University Hospital Inselspital | Recruiting |
Bern, Switzerland, 3010 | |
Sub-Investigator: Paul Mohacsi, Prof | |
Sub-Investigator: Tobias Rutz, MD | |
Sub-Investigator: Stéphane Cook, MD | |
Sub-Investigator: Rolf Vogel, MD PhD | |
Sub-Investigator: Thomas Schaffner, Prof. | |
Sub-Investigator: Steffen Gloekler, MD |
Principal Investigator: | Christian Seiler, Prof. | University Hospital Bern, Switzerland |
Study ID Numbers: | 216/06 |
Study First Received: | December 21, 2006 |
Last Updated: | December 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00414895 |
Health Authority: | Switzerland: Swissmedic |