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Absolute Myocardial Perfusion Measurement in the Transplanted Heart
This study is currently recruiting participants.
Verified by University Hospital Inselspital, Berne, December 2006
Sponsors and Collaborators: University Hospital Inselspital, Berne
Swiss National Science Foundation
Swiss Heart Foundation
Information provided by: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00414895
  Purpose

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
Cardiac Transplantation

U.S. FDA Resources
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

Further study details as provided by University Hospital Inselspital, Berne:

Estimated Enrollment: 90
Study Start Date: December 2006
Estimated Study Completion Date: June 2008
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with heart transplantation, age 18-82 years
  • EMB or EMB and coronary angiography
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Known adverse reaction to adenosine or echo contrast (SonoVueâ)
  • Second or third degree AV block, unprotected sick sinus syndrome, atrial fibrillation with uncontrolled ventricular rate
  • Asthma, severe pulmonary arterial hypertension (systolic pulmonary artery pressure >50mmHg assessed by echocardiography)
  • Severe obstructive pulmonary disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414895

Contacts
Contact: Tobias Rutz, MD +41 6321 12 77 tobias.rutz@insel.ch

Locations
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            
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Swiss Heart Foundation
Investigators
Principal Investigator: Christian Seiler, Prof. University Hospital Bern, Switzerland
  More Information

Study ID Numbers: 216/06
Study First Received: December 21, 2006
Last Updated: December 21, 2006
ClinicalTrials.gov Identifier: NCT00414895  
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on January 16, 2009