Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia
NCT ID: NCT06602934
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
300 participants
INTERVENTIONAL
2025-01-02
2029-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
NCT01730092
Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study
NCT02076061
Human Algorithm Interactions for Acute Respiratory Failure Diagnosis
NCT06098950
Analyzing Lung Tissue in People With and Without Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation
NCT00756522
Pulmonary Function, Chronic Obstructive Pulmonary Disease (COPD) Prevalence, and Systemic Inflammation in Chronic Heart Failure With or Without COPD
NCT01429376
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A : Patients with acute major cardiovascular event
Comparator
Blood samples
Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6, M18 and M30 (only at inclusion for group C).
Oropharyngeal swabs
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6, M18 and M30.
Calcium score (CT scan)
A calcium score will be taken at 30 months, to assess individual cardiovascular risk.
ECG
Performed at inclusion, M6, M18 and M30
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. These tests will be performed to assess respiratory and cardiac function.
Group B: Patients with severe chronic cardiovascular disease
Comparator
Blood samples
Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6, M18 and M30 (only at inclusion for group C).
Oropharyngeal swabs
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6, M18 and M30.
Calcium score (CT scan)
A calcium score will be taken at 30 months, to assess individual cardiovascular risk.
ECG
Performed at inclusion, M6, M18 and M30
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. These tests will be performed to assess respiratory and cardiac function.
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA
Comparator
Blood samples
Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6, M18 and M30 (only at inclusion for group C).
Oropharyngeal swabs
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6, M18 and M30.
Calcium score (CT scan)
A calcium score will be taken at 30 months, to assess individual cardiovascular risk.
ECG
Performed at inclusion, M6, M18 and M30
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. These tests will be performed to assess respiratory and cardiac function.
Group D: Patients cured of HAP
Blood samples
Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6, M18 and M30 (only at inclusion for group C).
Oropharyngeal swabs
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6, M18 and M30.
Calcium score (CT scan)
A calcium score will be taken at 30 months, to assess individual cardiovascular risk.
ECG
Performed at inclusion, M6, M18 and M30
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. These tests will be performed to assess respiratory and cardiac function.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood samples
Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6, M18 and M30 (only at inclusion for group C).
Oropharyngeal swabs
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6, M18 and M30.
Calcium score (CT scan)
A calcium score will be taken at 30 months, to assess individual cardiovascular risk.
ECG
Performed at inclusion, M6, M18 and M30
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. These tests will be performed to assess respiratory and cardiac function.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female
* Age ≥ 40years old
* Hospitalized for acute coronary syndrome for less than 7 days.
* Informed consent from the patient
* Person insured under a health insurance scheme
Group B (patients with chronic cardiovascular disease)
* Male or female,
* Age ≥ 40 years old
* Undergoing coronary artery by-pass surgery
* Hospitalized in intensive care unit for \> 12 hours
* Informed consent from the patient
* Person insured under a health insurance scheme
Group C (patients at risk of CVRD without chronic cardiovascular disease)
* Male or female,
* Age ≥ 40 years old
* Familial high levels of cholesterol or triglycerides
* With no personal history of CVRD, with a recent negative cardiac exercise test (last test inferior to 12 months)
* Follow-up for lipid abnormalities at high risk of CVRD events
* Informed consent from the patient
* Person insured under a health insurance scheme
Group D (patients with HAP)
* Male or female
* Age ≥ 40years old
* With one or more risk factors for CVD among:
smoking, abnormal lipidic levels, high blood pressure, obesity, diabetes mellitus, chronic kidney disease
* Cured from mechanically ventilated HAP during the current hospitalization
* Informed consent from the patient or relatives
* Person insured under a health insurance scheme
Exclusion Criteria
* Age \>80 years old
* Immunosuppression pre-existing to the index hospitalisation, defined as lymphopenia \< 500 elements/mm3, haematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug.
* Pregnant women, breastfeeding women.
* Adults under guardianship or trusteeship.
* Low probability of survival at day 28.
o Groups A, B, C
* Community-acquired pneumonia or Hospital-acquired pneumonia within the last year.
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Angers University Hospital
Angers, , France
Nantes University Hospital
Nantes, , France
Rennes University Hospital
Rennes, , France
Rouen University Hospital
Rouen, , France
Toulouse University Hospital
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sigismond LASOCKI
Role: backup
Cécile POULAIN
Role: backup
Yoann LAUNEY
Role: backup
Emmanuel BESNIER
Role: backup
Fanny BOUNES
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC24_0112
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.