Study Results
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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COMPLETED
41 participants
OBSERVATIONAL
2018-01-01
2022-01-01
Brief Summary
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The hypothesis is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.
The morphology will be described using T2-weighted non-contrast MRI.
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Detailed Description
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The hypothesis of the study is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.
The morphology will be described using T2-weighted non-contrast MRI. The main lymphatic vessel, the thoracic duct, will be rendered and measured using 3D software, and the lymphatic changes characterized by Dr. Yoav Dori (CHOP, Pennsylvania, USA), using a newly published grading system. The above will be correlated with the amount of complications experienced by the patients, and their physical capacity measured by both IPAQ questionaire and CPX test.
The study population consists of patients with a Fontan circulation operated at InCor Heart Institute, São Paulo, Brasil and Hospital das Clínicas, Ribeirão Preto, Brasil. Exclusion criteria were mental illness, genetic syndromes and age \<18 years. The patient group will be compared with age, gender and weight matched healthy controls.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Fontan Group
Fontan patients operated at the two centres between 1991 and 2014.
Non-contrast MRI
Classification and characterization of the lymphatic vasculature using non-contrast MRI.
Cardiopulmonary exercise test
Cardiopulmonary exercise test, measurement of VO2 and heart rate.
Healthy Control Group
Age, gender and weight matched healthy controls.
Non-contrast MRI
Classification and characterization of the lymphatic vasculature using non-contrast MRI.
Cardiopulmonary exercise test
Cardiopulmonary exercise test, measurement of VO2 and heart rate.
Interventions
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Non-contrast MRI
Classification and characterization of the lymphatic vasculature using non-contrast MRI.
Cardiopulmonary exercise test
Cardiopulmonary exercise test, measurement of VO2 and heart rate.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Mental illness
* Genetic syndromes
18 Years
100 Years
ALL
Yes
Sponsors
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InCor Heart Institute
OTHER
Hospital das Clínicas de Ribeirão Preto
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Department of Cardiothoracic and Vascular Surgery
Aarhus N, , Denmark
Countries
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Other Identifiers
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BRALYMF
Identifier Type: -
Identifier Source: org_study_id
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