Frailty Syndrome in Daily Practice of Interventional Cardiology Ward (FRAPICA)

Medical University of Silesia

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT03209414

Protocol ver. 1 08 May 2017

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged ≥ 65
• symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI
• written, informed consent

Exclusion criteria

• lack of consent

Trial design

1,000 participants in 4 patient groups

Stable coronary artery disease

Description:

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

Description:

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

Description:

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

Description:

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.