Absolute Myocardial Perfusion Measurement in the Transplanted Heart

Completed

• Conditions: Cardiac Transplantation

• Registration Number: NCT00414895
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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).

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-25
• Last Update Posted: 2010-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University Hospital Inselspital; 🇨🇭 Bern, Switzerland