Absolute Myocardial Perfusion Measurement in the Transplanted Heart
1 other identifier
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2006
CompletedFirst Posted
Study publicly available on registry
December 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedOctober 26, 2010
October 1, 2010
2 years
December 21, 2006
October 25, 2010
Conditions
Eligibility Criteria
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.
You may qualify if:
- Patients with heart transplantation, age 18-82 years
- EMB or EMB and coronary angiography
- Written informed consent to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insel Gruppe AG, University Hospital Bernlead
- Swiss National Science Foundationcollaborator
- Swiss Heart Foundationcollaborator
Study Sites (1)
University Hospital Inselspital
Bern, 3010, Switzerland
Related Publications (1)
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.
PMID: 23612502DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Seiler, Prof.
University Hospital Bern, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2006
First Posted
December 22, 2006
Study Start
December 1, 2006
Primary Completion
December 1, 2008
Study Completion
June 1, 2009
Last Updated
October 26, 2010
Record last verified: 2010-10