Valvular Microbiota and Valvulopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Detection of blood and tissue microbiota
研究概览
简要总结
Few teams in the world can reliably analyze tissue microbiota. In this regard, the present group has unique expertise in the analysis of blood and tissue microbiota, the first to describe in 2011.
Having a blood biomarker of this valve microbiota could help guide the therapeutic strategy before and after the intervention. This study will be the first to test the hypothesis that the analysis of the blood microbiota makes it possible to detect the carriage of a tissue microbiota in patients undergoing aortic valve replacement (AVR) for degenerative aortic valve disease and should also lay the foundations for a prospective study. intended to evaluate the impact of the blood and valve microbiota on the post-operative prognosis of these patients and the complications at one year. This would be a first proof of concept of the role of the tissue microbiota in valvular degeneration linked to aging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Indication for surgical AVR:
- •Tight RA:
- •symptomatic (dyspnea, syncope/lipothymia, angina);
- •and/or echocardiographic criterion:
- •valve surface < 1cm2 (and/or 0.6cm2/m2);
- •average transvalvular gradient > 40mmHg;
- •aortic jet velocity (Vmax) > 4.0m/s;
- •or low transvalvular gradient (mean gradient < 40mmHg) + left ventricular ejection fraction (LVEF) < 50% but contractile reserve;
- •and/or high calcium score on CT angiography;
- •Asymptomatic tight RA and:
- •LVEF < 50% without other cause;
- •and/or symptoms during exercise;
- •and/or low surgical risk + severity criteria: Vmax > 5.5m/s (or progression > 0.3m/s/year), NT-proBNP level > 3Xnormal, severe pulmonary arterial hypertension (pulmonary systolic pressure > 60mmHg);
- •Moderate AR + concomitant surgical indication for another heart disease;
- •Severe AI: regurgitant orifice > 30mm2, regurgitated volume > 60ml/beat,
- •symptomatic (dyspnea, syncope/lipothymia, angina);
- •and/or left ventricular dysfunction: LVEF < 50%, end-diastolic diameter > 70mm, end-systolic diameter > 50mm (or > 25mm/m2);
- •and/or concomitant surgical indication for another heart disease.
排除标准
- 未提供
研究组 & 干预措施
Collection of biological samples
The samples (1ml blood sample + approximately 90-100mg of valve tissue + saliva, periodontal and feces samples) will be collected at the time of T0 inclusion in the cardiovascular surgery department.
干预措施: Collection of biological samples (Biological)
结局指标
主要结局
Detection of blood and tissue microbiota
时间窗: 12 months
Detection of a blood microbiota in the pre-operative sample and a valve microbiota in the operating part.
次要结局
未报告次要终点