About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Blood samples
Other interventionFour 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).
Oropharyngeal swabs
Other interventionAn oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6 and M18.
ECG
Other interventionPerformed at inclusion, M6 and M18
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration
Other interventionCardiopulmonary 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.
Treatment groups
Trial outcomes
Primary outcomes
Major adverse cardiovascular events (MACE)
Major adverse cardiovascular events (MACE) at 6 months
Secondary outcomes
Rate of events
Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death
Rate of thrombo-embolic events
Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis
Rate of patients with poor cardiorespiratory fitness
Poor tolerance defined as VO2max lower than the normal values for age
Long-term CVD progression
* 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
Sponsors and contacts
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