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

Diagnosis Clinical Trial

— NEMANA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04865068
• Other study ID #: 87RI20_0020 /NEMANA
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: April 2021
• Source: University Hospital, Limoges
• Contact: Philippe Lacroix, Professor
• Phone: 0033555056391
• Email: philippe.lacroix[@]unilim.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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,

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis

Intervention

Diagnostic Test:
• Echocardiography measures on SSA participants
Upon SSA Subject is admitted to the hospital for an echocardiography, Information about this study process, Participants will receive an information note ; Administration of a medical history questionnaire, collection of cardiovascular risk factors, weight toe (all of which are routinely collected before an echocardiographic examination is performed); Performing and recording the echocardiographic examination according to routine protocol delivery of the results according to the usual management; deferred analysis of the recordings on workstation with classification of the data (normal-pathological) according to the different standards

Locations

Country	Name	City	State
France	Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects reclassified (from pathological to normal) according to the echocardiographic standard used (reference standard vs. TAHES standard).	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	18 months
Secondary	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	Identification and analyse the number of subjects requalified from pathological to normal) and identify reasons of the reclassifications after the use of the standards	18 months