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Trial record 74 of 359 for:    transthyretin

Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03322319
Recruitment Status : Completed
First Posted : October 26, 2017
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:
The frequency of cardiac amyloidosis among patients presenting with a so-called left ventricular hypertrophy remains unknown. This problem is especially relevant in the Caribbean's, where an amyloidosis-prone mutation of transthyretin gene might be frequent.

Condition or disease Intervention/treatment Phase
Left Ventricular Hypertrophy Procedure: Tissue biopsies Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis Biopsy

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Subtyping of cardiac amyloidosis [ Time Frame: 2 years ]
    To refine the genetic epidemiology of cardiac amyloidosis in the Caribbean's

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years,
  • Residency in French Caribbean Regions
  • Access to healthcare coverage,
  • Written informed consent obtained

Exclusion Criteria:

  • Evidence of another cause for left ventricular hypertrophy (uncontrolled severe high blood pressure, untreated severe aortic stenosis, family history of hypertrophic cardiomyopathy)
  • Inability to deliver informed consent,
  • Presence of a known severe disease impending participation in the study

Information from the National Library of Medicine

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 identifier (NCT number): NCT03322319

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Centre Hospitalier de Basse-Terre
Basse-Terre, Guadeloupe, 97100
CHU de Martinique
La Trinité, Martinique, 97220
Sponsors and Collaborators
University Hospital Center of Martinique
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Principal Investigator: Jocelyn INAMO, MD-PhD Centre Hospitalier Universitaire de Martinique, France

Publications of Results:
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Responsible Party: University Hospital Center of Martinique Identifier: NCT03322319     History of Changes
Other Study ID Numbers: 12/B/17
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD, all IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After the main publication of the results, for not limited time.
Access Criteria: The conditions for the transfer of all or part of the database of the research are decided by the investigator coordinator / sponsor of the research and are the subject of a written contract.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Center of Martinique:
Cardiac amyloidosis

Additional relevant MeSH terms:
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Hypertrophy, Left Ventricular
Proteostasis Deficiencies
Metabolic Diseases
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases