search
Back to results

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

Primary Purpose

Left Ventricular Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tissue biopsies
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Left Ventricular Hypertrophy focused on measuring Cardiac amyloidosis, Caribbean, Diagnosis, Transthyretin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de Basse-Terre
  • CHU de Martinique

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

left Ventricular Hypertrophy

Arm Description

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.

Outcomes

Primary Outcome Measures

Diagnosis of cardiac amyloidosis.
Diagnosis procedures involve clinical exam, echocardiography, MRI, SPECT, tissue biopsies, and will be realized following a diagnostic tree.

Secondary Outcome Measures

Subtyping of cardiac amyloidosis
To refine the genetic epidemiology of cardiac amyloidosis in the Caribbean's

Full Information

First Posted
October 23, 2017
Last Updated
October 26, 2017
Sponsor
University Hospital Center of Martinique
search

1. Study Identification

Unique Protocol Identification Number
NCT03322319
Brief Title
Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose)
Official Title
acTive scrEening of cArdiac aMyloidosis in the Caribbean's
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 23, 2013 (Actual)
Primary Completion Date
December 2, 2015 (Actual)
Study Completion Date
January 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Hypertrophy
Keywords
Cardiac amyloidosis, Caribbean, Diagnosis, Transthyretin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
left Ventricular Hypertrophy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tissue biopsies
Intervention Description
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 Measure Information:
Title
Diagnosis of cardiac amyloidosis.
Description
Diagnosis procedures involve clinical exam, echocardiography, MRI, SPECT, tissue biopsies, and will be realized following a diagnostic tree.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Subtyping of cardiac amyloidosis
Description
To refine the genetic epidemiology of cardiac amyloidosis in the Caribbean's
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn INAMO, MD-PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Martinique, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Basse-Terre
City
Basse-Terre
ZIP/Postal Code
97100
Country
Guadeloupe
Facility Name
CHU de Martinique
City
La Trinité
ZIP/Postal Code
97220
Country
Martinique

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD, all IPD that underlie results in a publication.
IPD Sharing Time Frame
After the main publication of the results, for not limited time.
IPD Sharing 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.
Citations:
PubMed Identifier
25803389
Citation
Oliveira Da Silva L, Fabre J, Monfort A, Villeret J, Citony I, Cohen-Tenoudji P, Lebbadi M, Martin D, Molinie V, Inamo J. 'Green Apple' Heart Failure. West Indian Med J. 2014 Jul 3;63(6):673-5. doi: 10.7727/wimj.2013.255. Epub 2014 Jun 25.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs