Informations générales (source: ClinicalTrials.gov)
Development of the Purification of Human Cardiac Mitochondria, Characterization of These Organelles and Validation of the Model in Acute Endocarditis and Obesity (MITHOM)
Observational
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
octobre 2018
septembre 2020
29 juin 2024
Data about human cardiac mitochondria are cruelly lacking in the literature. However,
damages of the activity of these organelles are often the source of abnormal cardiac
function in several pathologies. The purpose of this study is to develop a model of
purified human cardiac mitochondria, to verify the purity of these organelles and to
validate the authenticity of their function in acute endocarditis and obesity, two
situations known to alter their activity. Animal studies have shown that microbial
infection reduced mitochondrial metabolism whereas obesity increases it. The
investigator's hypotheses are the following: 1) acute endocarditis, a form of cardiac
microbial infection, reduces the function of human cardiac mitochondria; 2) obesity (body
mass index > 30) activates the metabolism of human cardiac mitochondria.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Chu Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Lise LACLAUTRE | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- For the controls : adult patients with normal body weight (23 < BMI < 27)
necessitating a cardiac surgery with sternotomy and extracorporeal circulation for
myocardial revascularization or valve replacement
- For endocarditis : adult patients with normal body weight (23 < BMI < 27) and
endocarditis of bacterial origin necessitating a cardiac surgery with sternotomy and
extracorporeal circulation in order to cure a major valve regurgitation or
vegetation with higher size than 15 mm with embolic risk
- For obese patients: adult patients with high body weight (BMI > 30 and waist to hip
ration > or = 1 for men and 0.85 for women) necessitating a cardiac surgery with
sternotomy and extracorporeal circulation for myocardial revascularization or valve
replacement
For all the patients:
- Ability to furnish an enlightened agreement
- Menbership of the French social security insurance
- For the controls : adult patients with normal body weight (23 < BMI < 27)
necessitating a cardiac surgery with sternotomy and extracorporeal circulation for
myocardial revascularization or valve replacement
- For endocarditis : adult patients with normal body weight (23 < BMI < 27) and
endocarditis of bacterial origin necessitating a cardiac surgery with sternotomy and
extracorporeal circulation in order to cure a major valve regurgitation or
vegetation with higher size than 15 mm with embolic risk
- For obese patients: adult patients with high body weight (BMI > 30 and waist to hip
ration > or = 1 for men and 0.85 for women) necessitating a cardiac surgery with
sternotomy and extracorporeal circulation for myocardial revascularization or valve
replacement
For all the patients:
- Ability to furnish an enlightened agreement
- Menbership of the French social security insurance
- Criteria linked to the surgery:
- Surgery of pressing emergency
- Aortic dissection
- Redux surgery
Criteria linked to the patient:
- Protocol refusal
- Protected adult patients
- Previous psychiatric pathology including known addiction states
- Physical or intellectual inability
- Preexisting pathologies such as respiratory failure
- Cardiac failure (ejection fraction < 30% pulmonary hypertenstion > 80 mmHg); aortic
counterpulsation; pre-operatory cardiogenic shock
- Severe acute or chronic renal failure with creatinine clearance < 40 ml/min
- Inherited dyslipidemia
- Previous cardiac or thoracic surgery with pericardium opening
- Severe hepatic failure and severe chronic hepatic pathologies
- Evolving neoplasia
- Patients with long course corticoid treatment and with inflammatory diseases
- Patients with double anti-platelet treatment not stopped 48h before the surgery
- Protected people not involved in the study: pregnant women, nursing women,
guardianship, deprived of liberty,