IncIncidence and Prognosis of Coronary Artery Disease in Elderly People Over 80 Years Referred for TAVI
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Comparison of the incidence of major cardio-vascular event
研究概览
简要总结
The investigators prognostic impact of coronary artery disease (CAD) and of percutaneous coronary intervention (PCI) in patients with indication of TAVI is controversial, particularly in elderly population where CAD and aortic stenosis (AS) are frequent and commonly coexisted. (1-2) The primary end point of this prospective study is to compare major cardiovascular event at one year of follow up in patients over 80 years with severe aortic stenosis who referred for TAVI with or without associated CAD.
The investigators will also assess (secondary endpoint) the impact of PCI on symptoms, major events and quality of life using geriatric parameters. The study will be conducted in the University hospital of Montpellier between November 2020 and November 2022
详细描述
Patients will be prospectively included in the study when aged of 80 years old or over and referred for TAVI at the university hospital of Montpellier.
Two groups of patients will be considered after coronary angiography which is systematic before TAVI Group 1: patients with significant > 50 % narrowing coronary stenosis ( revascularization by PCI / no revascularization) Group 2: No coronary lesion
Considering an end point at 1 year and a precision wished to i ± 6 percent with an alpha risk of 5 %, it's proposed , by the formula p= [(1.96)2 x [p(1-p)] / i2 ], a number of 170 subjects needed to highlight a incidence of major cardio-vascular event of 20 percent in the studied population.
Data collection by informatic files will include :
- Cardio vascular risk factor and medical history with evaluation of Charlston score
- Previous drug therapy
- Lifestyle : living alone or not, nursing home, ; home help
- Symptoms (angina (CSS classification) ; dyspnea (NHYA classification))
- Renal function (DFG) at admission
- Results of coronary angiography (number of lesions, proximal or non proximal, location of coronary stenosis)
- Geriatric assessment : autonomy, disability in daily living, weigh, BMI, falls, cognitive functions tests, assessment of the mood state by GDS
- Results of TAVI (success and complications of the procedure according to VARC2 criteria)
- Results of coronary revascularization if performed
- Length of hospitalisation for TAVI (days), length of stay in ICU (Intensive Care Unit) if necessary
- Events during the hospitalisation for TAVI (VARC and BARC criterias)
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of the incidence of major cardio-vascular event
时间窗: 1 year
Comparison of the incidence of major cardio-vascular event at one year follow up in elderly 80 or over referred for TAVI with (group 1) or without CAD (group 2). Major cardio vascular events evaluated at 1 year follow-up include: * Death (total and cardiovascular) * ischemic stroke, * haemorrhagic stroke, * acute coronary syndrome, * severe angina (\> class 2), * major bleeding or vascular complications (\>BARC2), * Re-hospitalisation for cardiac events
次要结局
- Length of hospitalisation(1 year)
- Incidence of CAD(1 year)
- Quality of life with assessment of clinical status(1 year)
- Rate of vascular/bleeding events according to strategy of care (PCI/no PCI)(1 year)
- Re-hospitalization for cardiac events(1 year)
- Rate of ischaemic(1 year)