Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Major adverse cardiovascular events (MACE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •o Groups A, B, C
- •Community-acquired pneumonia or Hospital-acquired pneumonia within the last year.
研究组 & 干预措施
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA
Comparator
干预措施: ECG (Other)
Group A : Patients with acute major cardiovascular event
Comparator
干预措施: Blood samples (Other)
Group A : Patients with acute major cardiovascular event
Comparator
干预措施: Oropharyngeal swabs (Other)
Group A : Patients with acute major cardiovascular event
Comparator
干预措施: ECG (Other)
Group B: Patients with severe chronic cardiovascular disease
Comparator
干预措施: Blood samples (Other)
Group B: Patients with severe chronic cardiovascular disease
Comparator
干预措施: Oropharyngeal swabs (Other)
Group B: Patients with severe chronic cardiovascular disease
Comparator
干预措施: ECG (Other)
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA
Comparator
干预措施: Blood samples (Other)
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA
Comparator
干预措施: Oropharyngeal swabs (Other)
Group D: Patients cured of HAP
干预措施: Blood samples (Other)
Group D: Patients cured of HAP
干预措施: Oropharyngeal swabs (Other)
Group D: Patients cured of HAP
干预措施: ECG (Other)
Group A : Patients with acute major cardiovascular event
Comparator
干预措施: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration (Other)
Group B: Patients with severe chronic cardiovascular disease
Comparator
干预措施: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration (Other)
Group D: Patients cured of HAP
干预措施: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration (Other)
结局指标
主要结局
Major adverse cardiovascular events (MACE)
时间窗: 6 months
Major adverse cardiovascular events (MACE) at 6 months
次要结局
- EPICES (Evaluation of precariousness and health inequalities in health examination centers) score(Month 6, Month 18 and Month 30)
- Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27(Month 6 and Month 18)
- Glasgow Outcome Scale Extended values(Month 6 and Month 18)
- Brief Pain Inventory score(Month 6 and Month 18)
- Rates of patients with chronic pain(Month 6 and Month 18)
- Rates of patients with severe symptoms of anxiety(Month 6 and Month 18)
- Mean Satisfaction With Life Scale (SWLS) score(Month 6 and Month 18)
- Correlation between SWLS and EQ-5D-5L dimensions and utility scores(Month 6 and Month 18)
- SF(Short Form)-36 score(Month 6 and Month 18)
- Mean QALYs (Quality-Adjusted Life-Years)(18 months)
- Modelisation of host-microbiome interactions(Month 0, Month 6 and Month 18)
- NYHA (New York Heart Association) classification(Month 6 and Month 18)
- Rate of events(Month 6 and Month 18)
- Rate of thrombo-embolic events(Month 6 and Month 18)
- Rate of patients with poor cardiorespiratory fitness(6 Month)
- Long-term CVD progression(Month 6 and Month 18)
- Rates of major respiratory events(Month 6 and Month 18)
- mMRC (Modified Medical Research Council) Dyspnoea Scale(Month 6 and Month 18)
- Rate of restrictive chronic respiratory distress(Month 6 and Month 18)
- 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(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(Month 6 and Month 18)
- Rate of patients with secondary lower respiratory tract infection(Month 6 and Month 18)
- Rate of patients with non-respiratory infection(Month 6 and Month 18)