NCT03690076Unknown不适用
Development of the Purification of Human Cardiac Mitochondria, Characterization of These Organelles and Validation of the Model in Acute Endocarditis and Obesity
University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年10月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mitochondrial function
研究概览
简要总结
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.
详细描述
3 groups of patients:
- Controls: patients with normal weight (23 < BMI < 27) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
- Endocarditis: patients with normal weight (23 < BMI < 27) carriers of endocarditis with surgery indication
- Obese: obese patients (BMI > 30) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
Comparisons studied:
- Controls vs. endocarditis
- Controls vs. obese patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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,
结局指标
主要结局
Mitochondrial function
时间窗: at day 1 (Moment of the surgery)
Measurement of oxidative phosphorylation and reactive oxygen species release in isolated human cardiac mitochondria
次要结局
- walk test(at the moment of inclusion in the study (day (-10-5)) and of the end of hospitalization (day +7+10))
- body composition(1 day before the surgery)
- Electrocardiogram : Detections of the rates in events per min of arrhythmias(at days (-10-5), (+7+10), (+30) and (+90))
- Membrane lipid composition(at day 1 (at the day of surgery))
- Markers of oxidative stress in the plasma(at days (0) and (+30) for the plasma and day (0) for the myocardium)
- Concentrations of inflammation cytokines in the plasma(at days (-10-5), (0), (+1), (+2), (+7) and (+90))
- Semi-quantitative analysis of the amounts of approximatively 6000 molecules in the plasma by metabolomic and lipidomic techniques(at days (0) and (+30))
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(at day (+30))
- Patient follow-up during the hospital stay(morbi-mortality at day (+90))
- Morbi-mortality(measurement during the post-operative 90 days)
研究者
研究点 (1)
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