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临床试验/NCT03668821
NCT03668821招募中不适用

Vascular Frailty - An Observational Cohort Study

Imperial College London2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Correlation between electronic Frailty Index and survival and complication rate.

研究概览

简要总结

An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.

详细描述

Vascular surgical operations are major procedures with significant associated morbidity and mortality. Frailty is a major factor influencing surgical outcome, but the effect on morbidity/mortality and quality of life is poorly understood in vascular surgery. Activity levels play a significant role in frailty and in pre-intervention preparation. It is anticipated that as frailty levels increase, activity levels decrease. It is hypothesised that vascular surgery patients suffer from a high prevalence of frailty and that increasing frailty will lead to increased morbidity and mortality and decreased quality of life.

This initial study will provide the foundations to identify targets for improvement in degree of frailty, appropriateness for surgery and outcome.

This project aims to:

Assess and quantify the prevalence of frailty as well as recording activity levels in the vascular surgery patient cohort Explore the impact of frailty and pre-op activity on surgical outcomes in the vascular surgical patient cohort to guide surgical treatments as well as future studies aimed at improving frailty and activity and thereby quality of life.

Identification of an appropriate metric of frailty for this population group to include activity, is a secondary aim of this proposal.

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

入选标准

  • All patients attending for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation under the care of the Vascular Surgery team
  • Willing and able to give informed written consent

排除标准

  • Those unable to give informed written consent
  • Those <18 years of age
  • In the opinion of the investigator unable or unwilling to comply with the requirements of the study

结局指标

主要结局

Correlation between electronic Frailty Index and survival and complication rate.

时间窗: 6 months

Survival and rate of complication correlated with the pre-operative frailty score (electronic Frailty Index).

Correlation between Q Mortality Index and survival and complication rate.

时间窗: 6 months

Survival and rate of complication correlated with the pre-operative frailty score (Q Mortality Index).

Correlation between ACS Risk Calculator Score and survival and complication rate.

时间窗: 6 months

Survival and rate of complication correlated with the pre-operative frailty score (ACS Risk Calculator).

Correlation between V-Possum and survival and complication rate.

时间窗: 6 months

Survival and rate of complication correlated with the pre-operative frailty score (V-Possum).

次要结局

  • Quality of Life Pre and Post Surgery as measure by the EuroQoL EQ-5D questionnaire(6 months)
  • Activity Levels Pre and Post Surgery as measured by the General Practice Physical Activity Questionnaire(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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