FRAPICA: Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Sponsor

Medical University of Silesia (Other)

Overall Status

Unknown status

CT.gov ID

NCT03209414

Collaborator

(none)

1,000

Enrollment

Location

48.5

Anticipated Duration (Months)

20.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Frail Elderly Syndrome Coronary Heart Disease Acute Coronary Syndrome Coronary Artery Bypass Grafting Percutaneous Transluminal Coronary Angioplasty

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Actual Study Start Date :

May 17, 2017

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Stable coronary artery disease 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 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 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 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.

Outcome Measures

Primary Outcome Measures

Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale [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 [Up to hospital discharge, on average day 4]
Patients will be assessed with instrumental activities of daily living scale

Secondary Outcome Measures

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