Frailty Syndrome in Daily Practice of Interventional Cardiology Ward
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Frail Elderly Syndrome, Coronary Heart Disease, Acute Coronary Syndrome, Coronary Artery Bypass Grafting. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale [Time frame: Up to hospital discharge, on average day 4]
- Predischarge distribution of frailty syndrome according to instrumental activities of daily living scale [Time frame: Up to hospital discharge, on average day 4]
Secondary outcome measures (11)
- Results of interventional treatment [Time frame: Up to hospital discharge, on average day 4]
- Incidence of periprocedural infarction [Time frame: Up to hospital discharge, on average day 4]
- Incidence of contrast induced nephropathy [Time frame: Up to hospital discharge, on average day 4]
- Incidence of bleeding [Time frame: Up to hospital discharge, on average day 4]
- Major cardiovascular events [Time frame: 36 months]
- Major cardiovascular events [Time frame: 36 months]
- Major cardiovascular events [Time frame: 36 months]
- Major cardiovascular events [Time frame: 36 months]
- Major cardiovascular events [Time frame: 36 months]
- Major cardiovascular events [Time frame: 36 months]
- Major cardiovascular events [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- aged ≥ 65
- symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI
- written, informed consent
Exclusion criteria
- lack of consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- II Dept. of Cardiology in Zabrze Medical University of Silesia — Zabrze
Publications
- Woloszyn-Horak E, Salamon R, Chojnacka K, Brzosko A, Bieda L, Standera J, Ploszaj K, Stepien E, Nowalany-Kozielska E, Tomasik A. Frailty syndrome in daily practice of interventional cardiology ward-rationale and design of the FRAPICA trial: A STROBE-compliant prospective observational study. Medicine (Baltimore). 2020 Jan;99(5):e18935. doi: 10.1097/MD.0000000000018935. PMID 32000408
Identifiers
NCT: NCT03209414 · Protocol ver. 1 08 May 2017