Alteration of the Risk of CArdiovascular DIseases After Pneumonia (ARCADIA)

January 15, 2026 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2000000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The French National Health Data System (SNDS) is a database that centralizes health-related data covering over 99% of residents (Tuppin et al.). Its primary objective is to support epidemiological research and health care system evaluation. It enables longitudinal analyses of health care pathways by linking data sources through anonymized identifiers.

SNDS include information on reimbursed outpatient care and deliveries, hospital discharge summaries and medical procedures, death and related causes and list of pathologies requiring chronic care.

These datasets collectively enable large-scale population-based studies on health care utilization, costs, morbidity and mortality. SNDS enable epidemiological studies to be conducted with more than 10 years of hindsight on nearly 68 million people.

Description

Inclusion Criteria:

  • 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, 2024.
  • 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.

Exclusion Criteria:

  • Declared pneumonia between January 1, 2012 and December 31, 2014.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4-points MACE and 5-points MACE
Time Frame: 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.
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4-points chronic CVD
Time Frame: Up to 10 years

Secondary outcomes gather chronic CVD as follows:

  • Coronary Artery Disease (MeSH Unique ID: D003324)
  • Peripheral Arterial Disease (D058729)
  • Arterial cerebral disease, non-hemorrhagic
  • Heart failure (D006333) We will also consider a composite outcome, called "4-points chronic cardiovascular disease" (4-points chronic CVD), defined by the occurrence or diagnosis related to these pathologies. Its incidence will be compared between groups using an incidence density ratio (IDR) and its 95% confidence interval.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Antoine ROQUILLY, MD, PhD, Nantes Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC24_0112_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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