Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose)
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|ClinicalTrials.gov Identifier: NCT03322319|
Recruitment Status : Completed
First Posted : October 26, 2017
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Left Ventricular Hypertrophy||Procedure: Tissue biopsies||Not Applicable|
Cardiac amyloidosis is a very poorly known disease, in its frequency, its mechanisms, its treatment. This lack of knowledge is a major limitation to the improvement, indispensable, of the care of the patients. In clinical routine, particularly in West Indies-Guyana, cardiac amyloidosis is a disease poorly identified, whose management remains to be optimized. Concordant observations suggest that the frequency of the disease could be significant in the Antilles-Guyana: aging of the population, high frequency of an amyloidogenic mutation (Val122Il mutation of the transthyretin gene) found in 4% of the Afro-American population, recent identification in Martinique by a neurology team of a new founding mutation of the transthyretin gene that may cause the disease.
These elements justified the setting up of a multidisciplinary group whose objective is to contribute to the improvement of screening, treatment, and follow-up of patients with cardiac amyloidosis.
An identical diagnostic algorithm will be followed in all centers. Therapeutic management will be left to the discretion of the health care teams, who will be communicated regularly, the latest management recommendations.
A frequency of 30% is expected and will be assessed with a power of 80% and an alpha risk of 0.05. Quantitative and qualitative data will be described as usual. Differences between groups will be assessed with parametric or non-parametric tests.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||acTive scrEening of cArdiac aMyloidosis in the Caribbean's|
|Actual Study Start Date :||September 23, 2013|
|Actual Primary Completion Date :||December 2, 2015|
|Actual Study Completion Date :||January 18, 2016|
Experimental: left Ventricular Hypertrophy
Patients with left ventricular wall thickness measuring 15mm or more, or patients with a suggestive left ventricular echogenicity. Procedure/surgery will be performed following a diagnostic tree.
Procedure: Tissue biopsies
It is commonly accepted that the diagnosis of cardiac amyloidosis may be based on presence of characteristic cardiac abnormalities in echography, associated with the detection of bi-refractive appearance deposits in polarized light after congo red staining of a biopsy fragment.
Usually a biopsy of the abdominal fat or salivary glands can suffice. More rarely, in case of persistent doubt (eg negativity of congo red despite a characteristic appearance, which may occur in 20 to 30% of cases), it will be necessary to perform an endomyocardial biopsy (EMB).
- Diagnosis of cardiac amyloidosis. [ Time Frame: 3 months ]Diagnosis procedures involve clinical exam, echocardiography, MRI, SPECT, tissue biopsies, and will be realized following a diagnostic tree.
- Subtyping of cardiac amyloidosis [ Time Frame: 2 years ]To refine the genetic epidemiology of cardiac amyloidosis in the Caribbean's
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322319
|Centre Hospitalier de Basse-Terre|
|Basse-Terre, Guadeloupe, 97100|
|CHU de Martinique|
|La Trinité, Martinique, 97220|
|Principal Investigator:||Jocelyn INAMO, MD-PhD||Centre Hospitalier Universitaire de Martinique, France|