Absolute Myocardial Perfusion Measurement in the Transplanted Heart

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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).

Conditions

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Cardiac Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Department of Cardiology, University Hospital, CH-3010 Bern, Switzerland

Principal Investigators

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Christian Seiler, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bern, Switzerland

Locations

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University Hospital Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Rutz T, de Marchi SF, Roelli P, Gloekler S, Traupe T, Steck H, Eshtehardi P, Cook S, Vogel R, Mohacsi P, Seiler C. Quantitative myocardial contrast echocardiography: a new method for the non-invasive detection of chronic heart transplant rejection. Eur Heart J Cardiovasc Imaging. 2013 Dec;14(12):1187-94. doi: 10.1093/ehjci/jet066. Epub 2013 Apr 23.

Reference Type DERIVED

PMID: 23612502 (View on PubMed)

Other Identifiers

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216/06

Identifier Type: -

Identifier Source: org_study_id