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临床试验/NCT00901355
NCT00901355已完成不适用

Morbidity and Mortality Based on Blood Pressure and Arterial Stiffness in Institutionalized Persons Aged 80 and Over: Study PARTAGE (Predictive Values of Blood Pressure and Arterial Stiffness in Institutionalized Very Aged Population).

Central Hospital, Nancy, France6 个研究点 分布在 2 个国家目标入组 1,130 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,130
试验地点
6
主要终点
Total Mortality

研究概览

简要总结

Introduction: High blood pressure especially systolic hypertension is a common condition in the elderly and is considered as a major determinant not only of cardiovascular (CV) morbidity and mortality, but also of several other age-related diseases, frailty and loss of autonomy. Actually, the association between BP levels and morbidity and mortality in the very elderly persons with several co-morbidities remains a controversial issue

Objectives: The aim of the PARTAGE study (Predictive values of blood pressure and arterial stiffness in institutionalized very aged population)is to determine the predictive value of blood pressure (BP) and arterial stiffness for overall mortality, major cardiovascular events and cognitive decline in a large population of institutionalized subjects aged 80 and over.

Methods: The population is composed of 1130 subjects aged over 80, living in nursing home, included by four french university hospitals centre (Nancy, Dijon, Paris, Toulouse) and two Italian (Cesena, Verona). Subjects with severe dementia and a very low level of autonomy are excluded from the study During the first visit, blood pressure were measured using an automatic monitor by physician in sitting and standing position (clinical BP and Orthostatic BP) and by a self measurement of blood pressure 3 measurements, in the morning and the evening, during 3 consecutive days).

Arterial stiffness is evaluated by measuring the carotid-femoral and carotid-radial pulse wave velocity (PWV) with the PulsePen® automatic device. Deaths and cardiovascular events are recorded during a follow-up of 2 years.

The hypothesis of the PARTAGE longitudinal study is that in very elderly frail individuals with multiple co-morbidities, CV risk could be better evaluated by combining self-measurements of BP and direct evaluation of arterial stiffness which are less influenced by the above mentioned disease and co-morbidities.

详细描述

The aim of PARTAGE study (Predictive values of blood pressure and arterial stiffness in institutionalized very aged population) is to determine the predictive value of blood pressure (BP) and arterial stiffness estimated by pulse wave velocity (PWV) on overall mortality, major CV events and cognitive decline in a large population of subjects living in nursing homes aged 80 and over.

Method:

Participants are included if they are aged 80 year old and over, are institutionalized and if they have signed the informed consent.

Persons are excluded if they have severe dementia (Mini Mental Status Examination: MMSE<12), a low level of autonomy (Activity of daily living: ADL≤2) and they are under guardianship or "a measure of legal protection".

All geriatric assessment instruments and arterial measures are applied by several trained medical research teams (geriatricians, cardiologists, psychologists) present at each university hospitals centre. All medical teams received the same standard operating procedures. All the assessments are performed in the nursing homes.

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
80 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • women and men aged 80 year old and over
  • living in nursing home
  • who signed the informed consent.

排除标准

  • severe dementia (Mini Mental Status Examination: MMSE<12)
  • a low level of autonomy (Activity of daily living: ADL≤2)
  • under guardianship or "a measure of legal protection".

结局指标

主要结局

Total Mortality

时间窗: 2 years Follow-up

次要结局

  • Cardiovascular morbidity Cognitive decline(2 years follow-up)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (6)

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