Absolute Myocardial Perfusion Measurement in the Transplanted Heart

Cardiac Transplantation Clinical Trial

Official title:

Absolute Myocardial Perfusion Measurement in the Transplanted Heart: a New Method for Accurate Detection of Allograft Rejection. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414895
• Other study ID #: 216/06
• Status: Completed
• Phase: N/A
• First received: December 21, 2006
• Last updated: October 25, 2010
• Start date: December 2006
• Est. completion date: June 2009

Study information

• Verified date: October 2010
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Transplantation

Locations

Country	Name	City	State
Switzerland	University Hospital Inselspital	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Swiss Heart Foundation, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland,