跳至主要内容
临床试验/NCT06334705
NCT06334705招募中不适用

EGEA4: the 30-year Follow-up of the EGEA Study : Study of Markers of Cardiovascular Risk in Asthmatic and Non-asthmatic

Institut National de la Santé Et de la Recherche Médicale, France8 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
8
主要终点
Framingham score variability between asthmatics and non-asthmatics

研究概览

简要总结

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 140,000 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 3.6%.

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 and/or 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 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.

详细描述

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 140,000 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 3.6%, 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 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 and/or 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 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.

The main objectives of the EGEA4 study are:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Have participated in at least one of the previous EGEA surveys;
  • •to be affiliated to a social security scheme or to be a beneficiary of such a scheme.

排除标准

  • •Person deprived of liberty by judicial or administrative decision;
  • •Person subject to a legal protection measure (safeguard of justice, curatorship or guardianship).

研究组 & 干预措施

participants can take part in any examinations they wish

Other

干预措施: blood test, food collection, hair collection, calcium scan, etc. (Other)

结局指标

主要结局

Framingham score variability between asthmatics and non-asthmatics

时间窗: during clinical examination

The primary endpoint will be the variability of the Framingham score between asthmatics and non-asthmatics to assess the association between asthma and cardiovascular (CV) risk.

次要结局

  • validated predictive biomarkers of CV disease (NTproBNP, Troponin(I) hs),(during clinical examination)
  • Aortic pulse wave velocity(during clinical examination)
  • Soluble ST2(during clinical examination)
  • coronary calcium score(during clinical examination)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (8)

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