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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 September 2023 |
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Main ID: |
NCT03328338 |
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Date of registration:
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28/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Mitochondrial Function in Transthyretin Amyloidosis
MIT-Amylose |
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Scientific title:
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Mitochondrial Function in Transthyretin Amyloidosis : the MIT-AMYLOSE Study. |
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Date of first enrolment:
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July 17, 2018 |
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Target sample size:
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12 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03328338 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Martinique
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Contacts
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Name:
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Jocelyn INAMO, MD-PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Martinique |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have a parietal thickness measuring more than 15 mm on the echocardiography or have
structural and echogenicity abnormalities characteristic of cardiac amyloidosis,
- Live in Martinique,
- Accept the use of the residues coming from biopsies of the subcutaneous abdominal
adipose tissue performed during the medical care.
Exclusion Criteria:
- Be under 18 years old,
- Have a contraindication to subcutaneous biopsy,
- Be allergic to local anesthetics,
- Pregnant or nursing woman,
- Have a cardiovascular disease suggesting a secondary cardiac disease, such as
documented severe hypertension, valvular stenosis, or a known familial cardiomyopathy,
- Be major under guardianship / curatorship or deprived of liberty,
- Not be able to answer to a simple administrative questionnaire or to give freely its
non-opposition.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiac Amyloidosis
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Primary Outcome(s)
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Oxygen consumption measure in subcutaneous abdominal fat biopsies
[Time Frame: Three months]
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Secondary Outcome(s)
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Rates of oxygen consumption
[Time Frame: Three months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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