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

NCT04865068 | Unknown

• 1 other identifier: 87RI20_0020 /NEMANA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Diagnosis

Keywords

Echocardiography, Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Arms (1)

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

EXPERIMENTAL

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

Diagnostic Test: Echocardiography measures on SSA participants

Interventions

Echocardiography measures on SSA participants 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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead
• University Hospital, Bordeaux: collaborator

Study Sites (1)

Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)

Limoges, 87000, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Lacroix, Professor

  0033555056391

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Lacroix, Professor

CONTACT

0033555056391; philippe.lacroix@unilim.fr

Arnaud Garcia, PhD

CONTACT

0033555087148; drc@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 29, 2021
• Study Start: June 1, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

FR (1)