Идёт набор NCT06602934

Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia

Без фазы С лечением Hospital Acquired Pneumonia (HAP) Cardiovascular and Respiratory Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Blood samples, Oropharyngeal swabs, ECG, Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration.
Кому может быть актуально: Состояния в реестре: Hospital Acquired Pneumonia (HAP), Cardiovascular and Respiratory Disease. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia

Обзор

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.

Вмешательства

Другое Blood 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).
Другое Oropharyngeal swabs
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6 and M18.
Другое ECG
Performed at inclusion, M6 and M18
Другое Cardiopulmonary 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.

Первичные конечные точки

Major adverse cardiovascular events (MACE) [Срок оценки: 6 months]

Вторичные конечные точки (12)

Rate of events [Срок оценки: Month 6 and Month 18]
Rate of thrombo-embolic events [Срок оценки: Month 6 and Month 18]
Rate of patients with poor cardiorespiratory fitness [Срок оценки: 6 Month]
Long-term CVD progression [Срок оценки: Month 6 and Month 18]
Rates of major respiratory events [Срок оценки: Month 6 and Month 18]
NYHA (New York Heart Association) classification [Срок оценки: Month 6 and Month 18]
mMRC (Modified Medical Research Council) Dyspnoea Scale [Срок оценки: Month 6 and Month 18]
Rate of restrictive chronic respiratory distress [Срок оценки: Month 6 and Month 18]
Rate of obstructive chronic respiratory distress progression [Срок оценки: Month 6 and Month 18]
Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex [Срок оценки: 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 [Срок оценки: Month 6 and Month 18]
Rate of patients with secondary lower respiratory tract infection [Срок оценки: Month 6 and Month 18]

Критерии участия

Критерии включения

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

Критерии исключения

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