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临床试验/NCT03209414
NCT03209414招募中不适用

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年5月17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
1,000
试验地点
1
主要终点
Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale

研究概览

简要总结

The impact of frailty on immediate and long term outcomes of invasive treatment of coronary artery disease is not fully characterized. The assessment of frailty may help physicians in the selection of best treatment option and in the timing and modality of the follow-up. The FRAilty syndrome in daily Practice of Interventional CArdiology ward (FRAPICA) study is designed with the aim to validate the use of the Fried frailty scale and instrumental activities of daily living scale (IADL) as prognostic tools in patients admitted to hospital for symptomatic coronary artery disease, either stable, unstable, or acute coronary syndrome (ACS).

The FRAPICA study is a single center prospective study enrolling patients aged ≥65 years. The aims are (1) to describe Fried frailty scale and IADL scale distribution before hospital discharge and (2) to investigate the prognostic role of Fried frailty and IADL scores. The outcomes are: (1) results of invasive treatment, (2) its complications (periinterventional MI, contrast-induced nephropathy, blood loss), (3) three-year all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, reintervention, heart failure, hospital readmission for any cause, and a composite of the above mentioned. Ancillary analyses will be focused on different clinical presentations, different tools to assess frailty and risk stratification.

The FRAPICA program will fill critical gaps in the understanding of the relation between frailty, cardiovascular disease, interventional procedures and outcome. It will enable more personalized risk assessment and identification of new targets for interventions.

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

入选标准

  • aged ≥ 65
  • symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI
  • written, informed consent

排除标准

  • lack of consent

结局指标

主要结局

Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale

时间窗: Up to hospital discharge, on average day 4

Patients will be assessed with Fried frailty scale

Predischarge distribution of frailty syndrome according to instrumental activities of daily living scale

时间窗: Up to hospital discharge, on average day 4

Patients will be assessed with instrumental activities of daily living scale

次要结局

  • Incidence of bleeding(Up to hospital discharge, on average day 4)
  • Major cardiovascular events(36 months)
  • Incidence of contrast induced nephropathy(Up to hospital discharge, on average day 4)
  • Incidence of periprocedural infarction(Up to hospital discharge, on average day 4)
  • Results of interventional treatment(Up to hospital discharge, on average day 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrzej Tomasik MD PhD FESC

Assistant professor

Medical University of Silesia

研究点 (1)

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