Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334705
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-18
Brief Title:
EGEA4 THE 30 YEAR FOLLOW UP OF THE EGEA STUDY
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
EGEA4 the 30-year Follow-up of the EGEA Study Study of Markers of Cardiovascular Risk in Asthmatic and Non-asthmatic
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiovascular CV diseases affect 523 million people worldwide and are the leading cause of death accounting for over 18 million deaths around 30 of all deaths every year CV diseases account for around 45 of all deaths in Europe or around 140000 deaths a year in France Asthma is one of the main non-communicable diseases with a significant societal and individual burden particularly in subjects suffering from severe asthma The prevalence of asthma worldwide has risen rapidly over the past five decades and now affects 272 million people worldwide representing a prevalence of around 36
Asthma is often associated with multimorbidity Allergic rhinitis chronic sinusitis sleep apnea syndrome gastro-oesophageal reflux disease obesity and hormonal disorders are among the most common conditions associated with asthma More recently other chronic conditions linked to asthma have been suggested including CV diseases
Although data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events the underlying mechanisms remain poorly understood In particular it is not known whether asthma and CV disease share common etiological processes such as anthropometric parameters lifestyle social environmental andor genetic factors or whether CV disease is a direct consequence of certain features of asthma such as systemic inflammation or asthma treatments
Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma which is supported by a growing body of scientific dataHowever it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV health
We hypothesize that asthma and more specifically adult and moderate-to-severe asthma are associated with early markers of CV risk Furthermore by providing a better understanding of the mechanisms involved in this association we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma
Asthma is often associated with multimorbidity Allergic rhinitis chronic sinusitis sleep apnea syndrome gastro-oesophageal reflux disease obesity and hormonal disorders are among the most common conditions associated with asthma More recently other chronic conditions linked to asthma have been suggested including CV diseases
Although data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events the underlying mechanisms remain poorly understood In particular it is not known whether asthma and CV disease share common etiological processes such as anthropometric parameters lifestyle social environmental andor genetic factors or whether CV disease is a direct consequence of certain features of asthma such as systemic inflammation or asthma treatments
Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma which is supported by a growing body of scientific dataHowever it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV health
We hypothesize that asthma and more specifically adult and moderate-to-severe asthma are associated with early markers of CV risk Furthermore by providing a better understanding of the mechanisms involved in this association we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma
Detailed Description:
Cardiovascular CV diseases which include coronary heart disease and stroke affect 523 million people worldwide and are the leading cause of death accounting for over 18 million deaths around 30 of all deaths every year CV diseases account for around 45 of all deaths in Europe or around 140000 deaths a year in France Asthma is one of the main non-communicable diseases with a significant societal and individual burden particularly in subjects suffering from severe asthma The worldwide prevalence of asthma has risen rapidly over the past five decades and now affects 272 million people worldwide representing a prevalence of around 36 with considerable geographical variability
Multimorbidity is common in asthma Allergic rhinitis chronic sinusitis sleep apnea syndrome gastroesophageal reflux disease obesity and hormonal disorders are among the most common conditions linked to asthmaMore recently other chronic conditions linked to asthma have been suggested including CV diseasesAlthough data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events the underlying mechanisms remain poorly understood In particular it is not known whether asthma and CV disease share common etiological processes such as anthropometric parameters lifestyle social environmental andor genetic factors or whether CV disease is a direct consequence of certain features of asthma such as systemic inflammation or asthma treatments
Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma which is supported by a growing body of scientific data
However it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV healthWe hypothesize that asthma and more specifically adult and moderate-to-severe asthma are associated with early markers of CV risk Furthermore by providing a better understanding of the mechanisms involved in this association we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma
The main objectives of the EGEA4 study are
1 to characterize the longitudinal association between asthma and cardiovascular CV risk assessed by the Framingham score
2 study the association between asthma and other CV risk markers such as aortic pulse wave velocity aPWV validated predictive biomarkers of CV disease NTproBNP TroponinI hs a promising CV biomarker ST2 soluble and coronary calcium score CAC
3 to study the association between asthma control and severity and various markers of CV risk
To meet the studys objectives volunteers from the EGEA study recruited between 1991-95 in 5 centers Paris Grenoble Lyon Montpellier Marseille and who have not dropped out will be contacted to take part in a new follow-up EGEA4
The new follow-up will consist of a clinical visit to
administer a standardized face-to-face or postal questionnaire similar to that used in previous EGEA surveys to assess respiratory and allergic symptoms and diseases the presence of chronic comorbidities including CV events eg stroke arteriosclerosis heart attack quality of life asthma control lifestyle diet using a validated food frequency questionnaire to assess average dietary intake over the past 12 months social and environmental factors eg smoking and indoor environment
perform a clinical examination including
anthropometric measurements height weight waist circumference and hip circumference and impedance measurement
blood pressure measurements
spirometry to measure pulmonary function
a one-minute chair-lift test to assess functional capacity
non-invasive measurement of an independent predictor of CV events the aortic pulse wave velocity aPWV estimated by the speed of the pulse wave between the ankle and wrist
take a hair sample
take a blood sample The visit will last 2h30 and will be carried out by clinical research staff trained in study procedures
A second visit will be offered to volunteers at the Grenoble and Paris centers to take a non-invasive measurement assessed by CT scan without injection the Coronary Calcium Score CAC which is a predictor of the risk of cardiovascular events If time permits CAC can be measured during the first visit
In addition following the first visit EGEA
equip the volunteer with an accelerometer Actigraph This accelerometer will be worn on the waist or wrist for one week
equip the volunteer with a passive pollution sensor NO2 The volunteer will wear the sensor for one week The sensor can be easily attached to a backpackhandbag
install the COBANET application on the volunteers phone and explain how to use it The purpose of this application is to collect information on the cleaning products used by the volunteer product name and barcode the frequency of use and the way in which these products are used with or without protection etc
provide the volunteer with a kit containing the materials needed to collect stool samples
create a Nutrinet account on the Nutrinet cohort platform where the participant will log on in the days following the visit to complete three 24-hour dietary records
Multimorbidity is common in asthma Allergic rhinitis chronic sinusitis sleep apnea syndrome gastroesophageal reflux disease obesity and hormonal disorders are among the most common conditions linked to asthmaMore recently other chronic conditions linked to asthma have been suggested including CV diseasesAlthough data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events the underlying mechanisms remain poorly understood In particular it is not known whether asthma and CV disease share common etiological processes such as anthropometric parameters lifestyle social environmental andor genetic factors or whether CV disease is a direct consequence of certain features of asthma such as systemic inflammation or asthma treatments
Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma which is supported by a growing body of scientific data
However it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV healthWe hypothesize that asthma and more specifically adult and moderate-to-severe asthma are associated with early markers of CV risk Furthermore by providing a better understanding of the mechanisms involved in this association we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma
The main objectives of the EGEA4 study are
1 to characterize the longitudinal association between asthma and cardiovascular CV risk assessed by the Framingham score
2 study the association between asthma and other CV risk markers such as aortic pulse wave velocity aPWV validated predictive biomarkers of CV disease NTproBNP TroponinI hs a promising CV biomarker ST2 soluble and coronary calcium score CAC
3 to study the association between asthma control and severity and various markers of CV risk
To meet the studys objectives volunteers from the EGEA study recruited between 1991-95 in 5 centers Paris Grenoble Lyon Montpellier Marseille and who have not dropped out will be contacted to take part in a new follow-up EGEA4
The new follow-up will consist of a clinical visit to
administer a standardized face-to-face or postal questionnaire similar to that used in previous EGEA surveys to assess respiratory and allergic symptoms and diseases the presence of chronic comorbidities including CV events eg stroke arteriosclerosis heart attack quality of life asthma control lifestyle diet using a validated food frequency questionnaire to assess average dietary intake over the past 12 months social and environmental factors eg smoking and indoor environment
perform a clinical examination including
anthropometric measurements height weight waist circumference and hip circumference and impedance measurement
blood pressure measurements
spirometry to measure pulmonary function
a one-minute chair-lift test to assess functional capacity
non-invasive measurement of an independent predictor of CV events the aortic pulse wave velocity aPWV estimated by the speed of the pulse wave between the ankle and wrist
take a hair sample
take a blood sample The visit will last 2h30 and will be carried out by clinical research staff trained in study procedures
A second visit will be offered to volunteers at the Grenoble and Paris centers to take a non-invasive measurement assessed by CT scan without injection the Coronary Calcium Score CAC which is a predictor of the risk of cardiovascular events If time permits CAC can be measured during the first visit
In addition following the first visit EGEA
equip the volunteer with an accelerometer Actigraph This accelerometer will be worn on the waist or wrist for one week
equip the volunteer with a passive pollution sensor NO2 The volunteer will wear the sensor for one week The sensor can be easily attached to a backpackhandbag
install the COBANET application on the volunteers phone and explain how to use it The purpose of this application is to collect information on the cleaning products used by the volunteer product name and barcode the frequency of use and the way in which these products are used with or without protection etc
provide the volunteer with a kit containing the materials needed to collect stool samples
create a Nutrinet account on the Nutrinet cohort platform where the participant will log on in the days following the visit to complete three 24-hour dietary records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A02312- 41 | REGISTRY | IDRCB | None |