Absolute Myocardial Perfusion Measurement in the Transplanted Heart

This study has been completed.
Sponsor:
Collaborators:
Swiss National Science Foundation
Swiss Heart Foundation
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00414895
First received: December 21, 2006
Last updated: October 25, 2010
Last verified: October 2010
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:

Enrollment: 90
Study Start Date: December 2006
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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
Sampling Method:   Probability Sample
Study Population

Prospective study with consecutive inclusion of transplanted patients undergoing follow-up exams. Examinations comprise endomyocardial biopsy (EMB) and, partly, coronary angiography on the subsequent day. Group A patients (i.e. those without coronary angiography) undergo MCE and pharmacologic stress with adenosine, the results of which are compared with the EMB done at the same day. If they have an acute rejection, they are reexamined during a histologically proven rejection free period, and the results are compared with those obtained during acute rejection. Group B patients (i.e. with EMB and coronary angiography) undergo the same procedure as in group A. Additionally, coronary collateral flow index (CFI) is obtained and an IVUS exam is performed during coronary angiography.

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00414895

Locations
Switzerland
University Hospital Inselspital
Bern, Switzerland, 3010
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

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Seiler, MD, Professor and Co-Chairman of Cardiology, Department of Cardiology, University Hospital, CH-3010 Bern, Switzerland
ClinicalTrials.gov Identifier: NCT00414895     History of Changes
Other Study ID Numbers: 216/06
Study First Received: December 21, 2006
Last Updated: October 25, 2010
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on July 26, 2014