About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged ≥ 65
symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI
written, informed consent
Disqualifiers
lack of consent
Trial population
The investigators assume to enroll consecutive 1000 patients with symptomatic coronary artery disease admitted to 2nd Dept. of Cardiology in Zabrze, Medical University of Silesia for coronary angiography or interventional treatment of the disease. Patients of both sexes aged ≥ 65 years are eligible. An information on study rationale, objectives, and methodology is presented to patients and written, informed consent is required to participate in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale
Patients will be assessed with Fried frailty scale
Predischarge distribution of frailty syndrome according to instrumental activities of daily living scale
Patients will be assessed with instrumental activities of daily living scale
Secondary outcomes
Results of interventional treatment
Number of patients with successful revascularization
Incidence of periprocedural infarction
Number of patients with periprocedural infarction
Incidence of contrast induced nephropathy
Number of patients with contrast induced nephropathy
Incidence of bleeding
Number of patients with bleeding
Sponsors and contacts
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