Absolute Myocardial Perfusion Measurement in the Transplanted Heart

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414895
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : October 26, 2010
Swiss National Science Foundation
Swiss Heart Foundation
Information provided by:
University Hospital Inselspital, Berne

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.

Condition or disease
Cardiac Transplantation

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).

Study Type : Observational
Actual Enrollment : 90 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00414895

University Hospital Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Swiss Heart Foundation
Principal Investigator: Christian Seiler, Prof. University Hospital Bern, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christian Seiler, MD, Professor and Co-Chairman of Cardiology, Department of Cardiology, University Hospital, CH-3010 Bern, Switzerland Identifier: NCT00414895     History of Changes
Other Study ID Numbers: 216/06
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2010