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The HOMI-LUNG - HAP study is part of the HOMI-LUNG project, funded by the Horizon Europe program. The "HOMI-LUNG" project is an international, interdisciplinary project that aims to better understand the causal links between respiratory tract infections (i.e. pneumonia) and the progression of cardiovascular disease. More specifically, the project aims to quantify the burden of cardiovascular disease after pneumonia and assess patients; acceptability of long-term health alterations, as well as to define pneumonia endotypes with distinct pathobiological mechanisms associated with exacerbation of cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A : Patients with acute major cardiovascular event | Other | Comparator |
|
| Group B: Patients with severe chronic cardiovascular disease | Other | Comparator |
|
| Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA | Other | Comparator |
|
| Group D: Patients cured of HAP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Other | Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6 and M18 (only at inclusion for group C). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events (MACE) | Major adverse cardiovascular events (MACE) at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of events | Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death | Month 6 and Month 18 |
| Rate of thrombo-embolic events |
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Inclusion Criteria:
Group A (patients with acute cardiac disease)
Group B (patients with chronic cardiovascular disease)
Group C (patients at risk of CVRD without chronic cardiovascular disease)
Group D (patients with HAP)
Age ≥ 65 years old Smoking, Abnormal lipidic levels, High blood pressure, Obesity, Diabetes mellitus, Chronic kidney disease
Exclusion Criteria:
Groups A, B, C and D
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine ROQUILLY | Contact | +33253482840 | Antoine.roquilly@univ-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital | Not yet recruiting | Angers | France |
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| Oropharyngeal swabs | Other | An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6 and M18. |
|
| ECG | Other | Performed at inclusion, M6 and M18 |
|
| Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration | Other | Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration: These tests will be performed consecutively for 2 hours at inclusion M6 and M18. These tests will be performed to assess respiratory and cardiac function. |
|
Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis
| Month 6 and Month 18 |
| Rate of patients with poor cardiorespiratory fitness | Poor tolerance defined as VO2max lower than the normal values for age | 6 Month |
| Long-term CVD progression |
| Month 6 and Month 18 |
| Rates of major respiratory events | Rates of major respiratory events are defined as COPD exacerbation, asthma exacerbation, hospitalization for respiratory failure, and respiratory-related mortality | Month 6 and Month 18 |
| NYHA (New York Heart Association) classification | NYHA (New York Heart Association) classification of dyspnea | Month 6 and Month 18 |
| mMRC (Modified Medical Research Council) Dyspnoea Scale | mMRC (Modified Medical Research Council) Dyspnoea Scale (Grade O to 4 : grade O = I only get breathless with strenuous exercise ; grade 4 : I am too breathless to leave the house or I am breathless when dressing/undressing) | Month 6 and Month 18 |
| Rate of restrictive chronic respiratory distress | Rate of restrictive chronic respiratory distress defined as% of patients withCPT (Total Lung Capacity) lower than normal values | Month 6 and Month 18 |
| Rate of obstructive chronic respiratory distress progression | Rate of obstructive chronic respiratory distress progression | Month 6 and Month 18 |
| Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex | Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex | Month 6 and Month 18 |
| Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex | Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex | Month 6 and Month 18 |
| Rate of patients with secondary lower respiratory tract infection | Rate of patients with secondary lower respiratory tract infection defined as clinical signs of infection with new infiltrate on Chest-X-Ray | Month 6 and Month 18 |
| Rate of patients with non-respiratory infection |
| Month 6 and Month 18 |
| Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27 | Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27 | Month 6 and Month 18 |
| Glasgow Outcome Scale Extended values | Glasgow Outcome Scale Extended values to assess global disability and recovery after traumatic brain injury | Month 6 and Month 18 |
| Brief Pain Inventory score | BPI score. This self-assessment questionnaire assesses the maind imensions of pain : intensity, functional disability, social and family repercussions and level of psychological distress (scale 0-10 : 0 = no pain , 10 = worst pain) | Month 6 and Month 18 |
| Rates of patients with chronic pain | Rates of patients with chronic pain (yes/no) as defined as worse pain score value within the last 24 hours superior to 3 | Month 6 and Month 18 |
| Rates of patients with severe symptoms of anxiety | Rates of patients with severe symptoms of anxiety defined as HADS_a and HADS_d >=11 | Month 6 and Month 18 |
| Mean Satisfaction With Life Scale (SWLS) score | Experience of CVRD progression from the patients' perspectives assessed by mean SWLS score | Month 6 and Month 18 |
| Correlation between SWLS and EQ-5D-5L dimensions and utility scores | Correlation between Satisfaction With Life Scale (SWLS) and 5-level EQ-5D dimensions and utility scores | Month 6 and Month 18 |
| SF(Short Form)-36 score | Patients' responses to the SF-36 to estimate the change in Health-Related Quality of Life (HRQoL) over time | Month 6 and Month 18 |
| Mean QALYs (Quality-Adjusted Life-Years) | Mean QALYs (Quality-Adjusted Life-Years) | 18 months |
| EPICES (Evaluation of precariousness and health inequalities in health examination centers) score | Rate of socio-economical precarity defined as EPICES (Evaluation of precariousness and health inequalities in health examination centers) score values > 30 at M6, 18 and M30 | Month 6, Month 18 and Month 30 |
| Modelisation of host-microbiome interactions | Modelisation of host-microbiome interactions | Month 0, Month 6 and Month 18 |
| Nantes University Hospital | Recruiting | Nantes | France |
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| Rennes University Hospital | Not yet recruiting | Rennes | France |
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| Rouen University Hospital | Not yet recruiting | Rouen | France |
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| Toulouse University Hospital | Not yet recruiting | Toulouse | France |
|
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
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