Clinical trial NCT04865068: Echocardiographic Standards and Sub-Saharian Africans (SSA) Migrants' in New Aquitaine Region
Official title: Echocardiographic Standards and Sub-Saharian Africans (SSA) Migrants' in New Aquitaine Region: NEMANA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnosis
Keywords: Echocardiography, Diagnosis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
First posted: 2021-04-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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,

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

Primary outcomes:
measure: Proportion of subjects reclassified (from pathological to normal) according to the echocardiographic standard used (reference standard vs. TAHES standard).
timeFrame: 18 months
Secondary outcomes:
measure: 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
timeFrame: 18 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)
Study officials:
affiliation: 0033555056391
name: Philippe Lacroix, Professor
role: PRINCIPAL_INVESTIGATOR
References: