DiagnosisNEMANANCT04865068
Echocardiographic Standards and Sub-Saharian Africans (SSA) Migrants' in New Aquitaine Region
A study testing Echocardiography measures on SSA participants in people with Diagnosis, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diagnosis
- What is being tested?
- Echocardiography measures on SSA participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- SSA Major Subjects (first generation or from or from first generation parents) admitted to the hospital for an echocardiography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)
Limoges, 87000
About this study
Official title: 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
Read the 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
- Being tested
- Echocardiography measures on SSA participants
- Keywords
- Echocardiography, Diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography measures on SSA participantsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Echocardiography measures on SSA participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Identification and analyse the number of subjects requalified from pathological to normal) and identify reasons of the reclassifications after the use of the standards
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Philippe Lacroix, Professor, Principal investigator, 0033555056391
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865068
- Sponsor's protocol ID
- 87RI20_0020 /NEMANA
- Acronym
- NEMANA
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Standards and Sub-Saharian Africans (SSA) Migrants' in New Aquitaine Region: NEMANA
- ClinicalTrials.gov ID
- NCT04865068
- Acronym / sponsor ID
- NEMANA / 87RI20_0020 /NEMANA
- Conditions
- Diagnosis
- Keywords
- Echocardiography, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African migrant's population located in la region New Aquitaine. | Experimental | Diagnostic Test: Echocardiography measures on SSA participantsEchocardiography norms will be harvested data on SSA participants located in la region New Aquitaine, France |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- SSA Major Subjects (first generation or from or from first generation parents) admitted to the hospital for an echocardiography
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography measures on SSA participantsUpon 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 | Diagnostic test | African migrant's population located in la region New Aquitaine. |
Primary outcome
Proportion of subjects reclassified (from pathological to normal) according to the echocardiographic standard used (reference standard vs. TAHES standard).
Time frame: 18 months
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
1 secondary outcome
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
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Lacroix, Professor principal investigator
0033555056391
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography measures on SSA participants in people with Diagnosis, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Lacroix, Professor (0033555056391, philippe.lacroix@unilim.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects reclassified (from pathological to normal) according to the echocardiographic standard used (reference standard vs. TAHES standard). (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.