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临床试验/NCT07357116
NCT07357116已完成不适用

Alteration of the Risk of CArdiovascular DIseases After Pneumonia: a Nationwide Observational Study Using the French Healthcare Claim Database

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 2,000,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,000,000
试验地点
1
主要终点
4-points MACE and 5-points MACE

研究概览

简要总结

Pneumonia can be acquired in the community (CAP) or during hospitalization (HAP). It is a leading cause of communicable diseases and the second cause of disability-adjusted life-years in the world (Roquilly et al., Shankar-Hari et al.). HAP is a common infectious disease, affecting up to 40% of patients on mechanical ventilation. It is a major global concern, with 500,000 cases treated annually in Europe. Despite European guidelines, the incidence remains high (Roquilly et al.), leading to significant medical consequences. Thanks to improved early detection and appropriate medical management, pneumonia-related mortality has steadily declined over the past decades. As a result, the number of patients surviving with potential long-term sequelae has increased, with risks of pulmonary function abnormalities, psychological disorders, and impaired quality of life (Shankar-Hari et al., Sipilä et al., Corrales-Medina et al., Ahmed et al.).

Cardiovascular and respiratory diseases (CVRD) are the most common pre-existing conditions in patients with pneumonia, with up to 40% of patients presenting these comorbidities at the time of pneumonia diagnosis (Roquilly et al., Nojiri et al.). The risk of severe cardiovascular and respiratory events increases after pneumonia recovery, with 14% of patients developing a CVRD event within the first year post-infection (Corrales-Medina et al., Herridge et al.), representing a 40% relative increase in CVRD risk compared to patients with CVRD without infection (Lai et al., Angriman et al.).

The objective of the ARCADIA study is to describe the incidence of cardiovascular diseases (CVD) in individuals surviving pneumonia and to compare it to that of patients with similar predisposing comorbidities for CVD but without a history of pneumonia. The investigators hypothesize that pneumonia is a cause of CVD so that patients with a history of pneumonia have a higher risk of developing CVD.

详细描述

Pneumonia is a leading cause of communicable diseases and the second cause of disability-adjusted life-years in the world (Roquilly et al., Shankar-Hari et al.). Pneumonia can be acquired in the community (community-acquired pneumonia, CAP) or during hospitalization (nosocomial, or Hospital-acquired pneumonia, HAP). CAP is classically induced by virulent bacteria (such as Streptococcus pneumoniae) or viruses (Flu), and new pathogenic viruses such as SARS-CoV2 (COVID-19) can rapidly diffuse in the population.

HAP is a common infectious disease, affecting up to 40% of patients on mechanical ventilation. It is a major global concern, with 500,000 cases treated annually in Europe. Despite European guidelines, the incidence remains high (Roquilly et al.), leading to significant medical consequences. Thanks to improved early detection and appropriate medical management, pneumonia-related mortality has steadily declined over the past decades. As a result, the number of patients surviving with potential long-term sequelae has increased, with risks of pulmonary function abnormalities, psychological disorders, and impaired quality of life (Shankar-Hari et al., Sipilä et al., Corrales-Medina et al., Ahmed et al.).

Cardiovascular and respiratory diseases (CVRD) are the most common pre-existing conditions in patients with pneumonia, with up to 40% of patients presenting these comorbidities at the time of pneumonia diagnosis (Roquilly et al., Nojiri et al.). The risk of severe cardiovascular and respiratory events increases after pneumonia recovery, with 14% of patients developing a CVRD event within the first year post-infection (Corrales-Medina et al., Herridge et al.), representing a 40% relative increase in CVRD risk compared to patients with CVRD without infection (Lai et al., Angriman et al.).

The ARCADIA study is part of the HOMI-LUNG project, funded by the Horizon Europe program. HOMI-LUNG is an international and interdisciplinary initiative aiming to better understand the causal links between respiratory infections (such as pneumonia) and the progression of CVRD. Specifically, the project seeks to quantify the burden of CVRD following pneumonia, assess patient acceptability of long-term health alterations, and define pneumonia endotypes with distinct pathobiological mechanisms associated with CVRD exacerbation.

The objective of the ARCADIA study is to describe the incidence of cardiovascular diseases (CVD) in individuals surviving pneumonia and to compare it to that of patients with similar predisposing comorbidities for CVD but without a history of pneumonia. The investigators hypothesize that pneumonia is a cause of CVD so that patients with a history of pneumonia have a higher risk of developing CVD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Be at least 18 years of age in the month of the index date.
  • Exposed group: participants who declared pneumonia between January 1, 2015 and November 30,
  • Unexposed group: participants who did not declare pneumonia between January 1, 2015 and index date and being selected after matching on age, sex, CVD history, chronic kidney disease, diabetes, antihypertensive deliveries, obesity, lipid-lowering treatments, alcohol and tobacco consumption.

排除标准

  • Declared pneumonia between January 1, 2012 and December 31,
  • Pneumonia before the age of 18 between January 1, 2015, and the index date.
  • Organ transplant receiver for any of the following organs before or within one year after the index date: heart, kidney, lung, liver, and pancreas.
  • Identifier that cannot be reliably tracked in the SNDS (such as a fictitious or provisional identifier, or an identifier that, under specific regimen, fails to distinguish same-sex twins in hospital records).
  • Death during index hospitalization.

研究组 & 干预措施

Exposed group

Exposure is defined as having reported any kind of pneumonia during the inclusion period. Once a participant has developed pneumonia, he or she belongs to the exposed group throughout the follow-up period.

Unexposed group

The unexposed group is made up of participants who have not developed pneumonia prior to inclusion and who have been matched to a participant in the exposed group on selected confounders.

结局指标

主要结局

4-points MACE and 5-points MACE

时间窗: Up to 10 years

Acute events relating to the following pathologies are the main outcomes of the ARCADIA study: * Acute Coronary Syndrome (MeSH Unique ID: D054058) * Lower limb revascularization or major amputation * Ischemic Stroke (D000083242) * Heart Failure (D006333) requiring Hospitalization (D006760) The primary outcome is therefore a composite outcome, called "4-points MACE", defined by the occurrence of at least one acute event related to the previously cited pathologies. The incidence of 4-point MACE will be compared between groups using an incidence density ratio (IDR) and its 95% confidence interval. This primary analysis will be replicated by adding all-cause mortality (MeSH Unique ID: D003643) to the 4-point MACE described above, defining a 5-points MACE.

次要结局

  • 4-points chronic CVD(Up to 10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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