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Coronary Artery Disease in Elderly People Referred for TAVI (CEPTAVI)

2021年6月10日 更新者:University Hospital, Montpellier

IncIncidence and Prognosis of Coronary Artery Disease in Elderly People Over 80 Years Referred for TAVI

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

研究概览

地位

招聘中

详细说明

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)

Follow up at 6 month (middle analysis) and at one year (primary end point) by phone conversation with the patient for assessment of :

  • Major cardio-vascular events
  • Hospitalisation occurred
  • Short geriatric evaluation including :

    • cognition by Ottawa3DY
    • autonomy by ADL
    • polypharmacy
    • number of fall in the past 6 month
    • last weight
    • quality of life (Fried criterias)
    • mood state by GDS If neurocognitive disorders are known or discovers, data patient's validity will be check by calling his caregiver and/or his general practitioner (if caregiver not available).

Analysis associated of the computerized patient record.

研究类型

观察性的

注册 (预期的)

170

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

80年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients aged of 80 years or over who are admitted in cardiology for TAVI

描述

Inclusion criteria:

  • patient aged 80 and over
  • hospital admission for evaluation before TAVI indicated for symptomatic and severe aortic stenosis
  • patient's consent

Exclusion criteria:

  • absence of coronarography
  • severe angina (class 3 or 4)
  • stenosis of left main coronary artery > 50%
  • stenosis of the left anterior descending artery > 90%
  • decision of surgical valve replacement

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Group 1 : Elderly 80 years or over patients referred for TAVI with CAD
Elderly 80 years or over patients referred for TAVI with CAD Group 1: Coronary lesion defined as significant (>50% narrowing) on the coronary angiography performed before TAVI, with or without PCI (decision of the heart team) Description of the coronary lesions included: proximal/non proximal, number of lesions, location of lesion
Group 2 : No significant coronary disease group
No significant coronary disease group in the cohort of elderly 80 years or over referred for TAVI

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Comparison of the incidence of major cardio-vascular event
大体时间: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
1 year

次要结果测量

结果测量
措施说明
大体时间
Incidence of CAD
大体时间:1 year
Incidence of CAD in the elderly over 80 years old during the pre TAVI evaluation Evaluate the coronary disease impact in the elderly over 80 referred for TAVI by the number of patients over 80 years with significant coronary lesions compared to global TAVI population over 80 years
1 year
Length of hospitalisation
大体时间:1 year

Length of hospitalisation with or without coronary disease, with or without PCI.

Length of hospitalisation in total and in the ICU if it's happened to evaluated the economic impact of CAD and therapeutic strategy.

1 year
Rate of ischaemic
大体时间:1 year
ischaemic event (acute coronary syndrome, severe angina)
1 year
Rate of vascular/bleeding events according to strategy of care (PCI/no PCI)
大体时间:1 year
minor bleeding (BARC 1 and 2) and major (BARC 3 et 4) event or vascular complication (VARC 2).
1 year
Re-hospitalization for cardiac events
大体时间:1 year
Re-hospitalization for cardiac events
1 year
Quality of life with assessment of clinical status
大体时间:1 year
Quality of life with assessment of clinical status by geriatrics tests geriatrics tests by phone interview of the patient
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Florence Leclercq, PU PH、University Hospital, Montpellier

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年11月1日

初级完成 (预期的)

2022年11月1日

研究完成 (预期的)

2023年11月1日

研究注册日期

首次提交

2021年5月25日

首先提交符合 QC 标准的

2021年6月10日

首次发布 (实际的)

2021年6月18日

研究记录更新

最后更新发布 (实际的)

2021年6月18日

上次提交的符合 QC 标准的更新

2021年6月10日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

NC

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