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Clinical Trials/NCT04865068
NCT04865068
Unknown
Not Applicable

Echocardiographic Standards and Sub-Saharian Africans (SSA) Migrants' in New Aquitaine Region: NEMANA

University Hospital, Limoges1 site in 1 country100 target enrollmentJune 1, 2021
ConditionsDiagnosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diagnosis
Sponsor
University Hospital, Limoges
Enrollment
100
Locations
1
Primary Endpoint
Proportion of subjects reclassified (from pathological to normal) according to the echocardiographic standard used (reference standard vs. TAHES standard).
Last Updated
5 years ago

Overview

Brief Summary

Standards Echocardiographic have been defined mainly on caucasian or Asian populations. In the EchoNoRMAL study the criteria for African populations were based solely on data from 198 subjects. This study suggests the presence of different standards depending on the ethnic origin of the subjects. The aims of this study is to describe the proportion of subjects reclassified (normal-pathological) according to the use of echocardiographic norm differences showed in TAHES population (Sub Saharian Africans) with those routinely used

Detailed Description

Sub-Saharian Africans populations seem to be more vulnerable in the field of health in general and in cardiovascular pathologies in particular. * The echocardiographic standards were mainly defined for Caucasian or Asian populations (EchoNoRMAL col. 2014 and 2015). In the EchoNoRMAL study, the criteria for the African populations were based on a reduced workforce (data from 198 subjects). * This study suggests the presence of different standards depending on the ethnic origin of the subjects. The authors noted that the establishment of references according to the ethnic origin of the subjects is necessary and highlighted the need for additional study for the underrepresented groups, in particular those including subjects of African origin. The need for different ECG standards in African subjects, was confirmed in a study in the general African population (TAHES), represents 16% of immigrants in 2015 (INSEE According to reports from the health insurance funds, the migrant population,

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
September 15, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Limoges
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • SSA Major Subjects (first generation or from or from first generation parents) admitted to the hospital for an echocardiography

Exclusion Criteria

  • Participation refusal;
  • Any acute heart disease (endocarditis, myocarditis, coronary syndrome);
  • Valvulopathy justifying an intervention;
  • Diseases of overload.
  • Any acute heart disease (endocarditis, myocarditis, coronary syndrome);
  • Valvulopathy justifying an intervention;
  • Diseases of overload.
  • Both participant and accompanying person unable to understand the information note written in French and in English

Outcomes

Primary Outcomes

Proportion of subjects reclassified (from pathological to normal) according to the echocardiographic standard used (reference standard vs. TAHES standard).

Time Frame: 18 months

Compare the echocardiography standards previously established in TAHES study to those used routinely managed for the population of SSA migrants in la region New Aquitaine, in order to define pathological subjects

Secondary Outcomes

  • Describe the reasons of reclassification, based on the change of echocardiography standards use for the following criteria: left ventricular hypertrophy, left atrial dilatation, aortic dilatation, ascending, right ventricular dilatation(18 months)

Study Sites (1)

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