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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diagnosis
• Intervention / Treatment: Diagnostic test: Echocardiography measures on SSA participants

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,

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Lacroix, Professor; Phone Number: 0033555056391; Email: philippe.lacroix@unilim.fr
• Study Contact Backup: Name: Arnaud Garcia, PhD; Phone Number: 0033555087148; Email: drc@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87000
    • Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Collaborators: University Hospital, Bordeaux
• Investigators: Principal Investigator: Philippe Lacroix, Professor, 0033555056391

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): September 15, 2022
• Study Completion (ANTICIPATED): September 15, 2022

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (ACTUAL): April 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Echocardiography, Diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 87RI20_0020 /NEMANA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No