Cardiovascular and Respiratory Disease, Hospital Acquired Pneumonia (HAP)
Conditions
Keywords
Hospital-acquired pneumonia, Cardiovascular and respiratory diseases, Respiratory microbiome
Brief summary
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.
Interventions
OTHERBlood samples
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).
OTHEROropharyngeal swabs
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6 and M18.
OTHERECG
Performed at inclusion, M6 and M18
OTHERCardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration
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.
Sponsors
Nantes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Group A (patients with acute cardiac disease) * Male or female * 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, * 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, * 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 * With one or more risk factors for CVD among: Age ≥ 65 years old 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACE) | 6 months | Major adverse cardiovascular events (MACE) at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of events | Month 6 and Month 18 | Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death |
| Rate of thrombo-embolic events | Month 6 and Month 18 | Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis |
| Rate of patients with poor cardiorespiratory fitness | 6 Month | Poor tolerance defined as VO2max lower than the normal values for age |
| Long-term CVD progression | Month 6 and Month 18 | * Decrease in VO2max measured by cardiopulmonary exercise stress testing * \- Rates of CVD are defined as * % patients with VO2max lower than normal values for age and sex. * % patients with new rhythm cardiac alterations, of new repolarisation abnormality |
| Rates of major respiratory events | Month 6 and Month 18 | Rates of major respiratory events are defined as COPD exacerbation, asthma exacerbation, hospitalization for respiratory failure, and respiratory-related mortality |
| NYHA (New York Heart Association) classification | Month 6 and Month 18 | NYHA (New York Heart Association) classification of dyspnea |
| mMRC (Modified Medical Research Council) Dyspnoea Scale | Month 6 and Month 18 | 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) |
| Rate of restrictive chronic respiratory distress | Month 6 and Month 18 | Rate of restrictive chronic respiratory distress defined as% of patients withCPT (Total Lung Capacity) lower than normal values |
| Rate of obstructive chronic respiratory distress progression | Month 6 and Month 18 | Rate of obstructive chronic respiratory distress progression |
| 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 diffusion capacity for carbon monoxide (DLCO) 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 | Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex |
| Rate of patients with secondary lower respiratory tract infection | Month 6 and Month 18 | Rate of patients with secondary lower respiratory tract infection defined as clinical signs of infection with new infiltrate on Chest-X-Ray |
| Rate of patients with non-respiratory infection | Month 6 and Month 18 | * Rates of patients with secondary lower respiratory tract infection defined as clinical signs of infection (fever, cough, hyperleukocytosis or leukopenia), with new infiltrate on Chest-X-Ray (performed as standard of care). * Rates of patients with non-respiratory infection defined as pyelonephritis, septicemia, skin infection or others. |
| Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27 | Month 6 and Month 18 | Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27 |
| Glasgow Outcome Scale Extended values | Month 6 and Month 18 | Glasgow Outcome Scale Extended values to assess global disability and recovery after traumatic brain injury |
| Brief Pain Inventory score | Month 6 and Month 18 | 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) |
| Rates of patients with chronic pain | Month 6 and Month 18 | Rates of patients with chronic pain (yes/no) as defined as worse pain score value within the last 24 hours superior to 3 |
| Rates of patients with severe symptoms of anxiety | Month 6 and Month 18 | Rates of patients with severe symptoms of anxiety defined as HADS\_a and HADS\_d \>=11 |
| Mean Satisfaction With Life Scale (SWLS) score | Month 6 and Month 18 | Experience of CVRD progression from the patients' perspectives assessed by mean SWLS score |
| Correlation between SWLS and EQ-5D-5L dimensions and utility scores | Month 6 and Month 18 | Correlation between Satisfaction With Life Scale (SWLS) and 5-level EQ-5D dimensions and utility scores |
| SF(Short Form)-36 score | Month 6 and Month 18 | Patients' responses to the SF-36 to estimate the change in Health-Related Quality of Life (HRQoL) over time |
| Mean QALYs (Quality-Adjusted Life-Years) | 18 months | Mean QALYs (Quality-Adjusted Life-Years) |
| EPICES (Evaluation of precariousness and health inequalities in health examination centers) score | Month 6, Month 18 and Month 30 | 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 |
| Modelisation of host-microbiome interactions | Month 0, Month 6 and Month 18 | Modelisation of host-microbiome interactions |
Countries
France
Contacts
CONTACTAntoine ROQUILLY
Outcome results
None listed