Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Study Overview
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Brief Summary
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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.

Official Title
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Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Conditions
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Frail Elderly Syndrome, Coronary Heart Disease, Acute Coronary Syndrome, Coronary Artery Bypass Grafting, Percutaneous Transluminal Coronary Angioplasty

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥ 65 symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI written, informed consent Exclusion Criteria: lack of consent

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stable coronary artery disease<br>Patients with stable effort angina wil be enrolled. Based on coronary angiography, heart team will decide on medical, percutaneous angioplasty, or bypass grafting. | |
| Unstable coronary artery disease<br>Patients with unstable angina wil be enrolled. Based on coronary angiography, heart team will decide on medical, percutaneous angioplasty, or bypass grafting. | |
| Non-ST elevation myocardial infarction<br>Patients with non-ST elevation myocardial infarction wil be enrolled. Based on coronary angiography, heart team will decide on medical, percutaneous angioplasty, or bypass grafting. | |
| ST-elevation myocardial infarction<br>Patients with ST elevation myocardial infarction wil be enrolled. In majority of patients primary percutaneous coronary intervention will be performed. Based on coronary angiography, heart team will decide on further medical treatment, percutaneous angioplasty, or bypass grafting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale | Patients will be assessed with Fried frailty scale | Up to hospital discharge, on average day 4 | 
| Predischarge distribution of frailty syndrome according to instrumental activities of daily living scale | Patients will be assessed with instrumental activities of daily living scale | Up to hospital discharge, on average day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of interventional treatment | Number of patients with successful revascularization | Up to hospital discharge, on average day 4 | 
| Incidence of periprocedural infarction | Number of patients with periprocedural infarction | Up to hospital discharge, on average day 4 | 
| Incidence of contrast induced nephropathy | Number of patients with contrast induced nephropathy | Up to hospital discharge, on average day 4 | 
| Incidence of bleeding | Number of patients with bleeding | Up to hospital discharge, on average day 4 | 
| Major cardiovascular events | Number of cardiovascular deaths in long term follow-up | 36 months | 
| Major cardiovascular events | Number of all-cause deaths in long term follow-up | 36 months | 
| Major cardiovascular events | Number of patients with reinfarction in long term follow-up | 36 months | 
| Major cardiovascular events | Number of patients with target lesion revascularization in long term follow-up | 36 months | 
| Major cardiovascular events | Number of patients with stroke in long term follow-up | 36 months | 
| Major cardiovascular events | Number of patients with new onset heart failure in long term follow-up | 36 months | 
| Major cardiovascular events | Number of patients rehospitalized for any cause in long term follow-up | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty syndrome, Coronary heart disease, Coronary revascularization, Major adverse cardiovascular events, Arterial stiffness, Applanation tonometry, Lean body mass, ST2 biomarker