Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorMedical University of Silesia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 4 trial groups
Group A: Stable coronary artery disease
Group B: Unstable coronary artery disease
Group C: Non-ST elevation myocardial infarction
Group D: ST-elevation myocardial infarction

Trial outcomes

Primary outcomes

1

Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale

Patients will be assessed with Fried frailty scale

Time frame
Up to hospital discharge, on average day 4
2

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

Patients will be assessed with instrumental activities of daily living scale

Time frame
Up to hospital discharge, on average day 4

Secondary outcomes

1

Results of interventional treatment

Number of patients with successful revascularization

Time frame
Up to hospital discharge, on average day 4
2

Incidence of periprocedural infarction

Number of patients with periprocedural infarction

Time frame
Up to hospital discharge, on average day 4
3

Incidence of contrast induced nephropathy

Number of patients with contrast induced nephropathy

Time frame
Up to hospital discharge, on average day 4
4

Incidence of bleeding

Number of patients with bleeding

Time frame
Up to hospital discharge, on average day 4

Other outcomes

Sponsors and contacts

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