Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Comparing biomarkers
研究概览
简要总结
Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. These elements may precede the onset of symptoms. The assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. This is part of a personalised medicine adapted to the patient.
Patients will be recruited during their TAVI (Transcatheter Aortic Valve Implantation) assessment consultation. If the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, TAVI procedure if applicable, biology).
Outside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present.
Patients will be divided into 3 groups according to the indication for TAVI (Group A - symptomatic severe aortic stenosis with indication for TAVI, Group B - asymptomatic severe aortic stenosis without indication for TAVI, Group C - asymptomatic moderate aortic stenosis without indication for TAVI).
The main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients >=18 years of age
- •Patient with symptomatic or asymptomatic severe or moderately severe aortic stenosis (according to the recommendations of the European Society of Cardiology - ESC).
- •No opposition.
排除标准
- •Conjunctive heart disease (e.g. amyloidosis).
- •Presence of a contraindication to TAVI.
- •Impossibility of giving the subject informed information.
- •Privation of civil rights (curatorship, tutorship, protection of justice).
研究组 & 干预措施
Group A
Patients with symptomatic severe aortic stenosis, with indication for TAVI. They are followed at inclusion, during hospitalisation of the TAVI procedure, at 1-month follow-up, at 1-year follow-up and by phone at 2 years follow-up.
干预措施: Quality of life questionnaires (Behavioral)
Group C
Patients with asymptomatic middle aortic stenosis, without indication for TAVI. They are followed at inclusion, at 1-month follow-up, at 1-year follow-up and at 2 years follow-up.
干预措施: Quality of life questionnaires (Behavioral)
Group B
Patients with asymptomatic severe aortic stenosis, without indication for TAVI. They are followed at inclusion, at 1-month follow-up, at 1-year follow-up and at 2 years follow-up.
干预措施: Quality of life questionnaires (Behavioral)
Group A
Patients with symptomatic severe aortic stenosis, with indication for TAVI. They are followed at inclusion, during hospitalisation of the TAVI procedure, at 1-month follow-up, at 1-year follow-up and by phone at 2 years follow-up.
干预措施: Biocollection (Biological)
Group B
Patients with asymptomatic severe aortic stenosis, without indication for TAVI. They are followed at inclusion, at 1-month follow-up, at 1-year follow-up and at 2 years follow-up.
干预措施: Biocollection (Biological)
Group C
Patients with asymptomatic middle aortic stenosis, without indication for TAVI. They are followed at inclusion, at 1-month follow-up, at 1-year follow-up and at 2 years follow-up.
干预措施: Biocollection (Biological)
结局指标
主要结局
Comparing biomarkers
时间窗: At V0 (inclusion), V4 (1-month follow up) and V5 (1-year follow up).
The primary endpoint is the level of biomarkers of inflammation and fibrosis in the 3 groups of patients.
次要结局
未报告次要终点