Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414895
Status:
COMPLETED
Last Update Posted:
2010-10-26
First Post:
2006-12-21
Brief Title:
Absolute Myocardial Perfusion Measurement in the Transplanted Heart
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Absolute Myocardial Perfusion Measurement in the Transplanted Heart a New Method for Accurate Detection of Allograft Rejection A Pilot Study
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None