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

NCT ID: NCT04865068

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-09-15

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,

Conditions

Diagnosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

African migrant's population located in la region New Aquitaine.

Echocardiography norms will be harvested data on SSA participants located in la region New Aquitaine, France

Group Type: EXPERIMENTAL

Echocardiography measures on SSA participants

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Lacroix, Professor

Role: PRINCIPAL_INVESTIGATOR

0033555056391

Locations

Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)

Limoges, , France

Countries

France

Central Contacts

Philippe Lacroix, Professor

Role: CONTACT

philippe.lacroix@unilim.fr

0033555056391

Arnaud Garcia, PhD

Role: CONTACT

drc@chu-limoges.fr

0033555087148

Other Identifiers

87RI20_0020 /NEMANA

Identifier Type: -

Identifier Source: org_study_id