Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Recruiting

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

• Registration Number: NCT03209414
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-17
• Study First Submitted: 2017-06-24
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• lack of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of bleeding	Up to hospital discharge, on average day 4	Number of patients with bleeding
Major cardiovascular events	36 months	Number of patients rehospitalized for any cause in long term follow-up
Incidence of contrast induced nephropathy	Up to hospital discharge, on average day 4	Number of patients with contrast induced nephropathy
Incidence of periprocedural infarction	Up to hospital discharge, on average day 4	Number of patients with periprocedural infarction
Results of interventional treatment	Up to hospital discharge, on average day 4	Number of patients with successful revascularization

Trial Locations

Locations (1)

II Dept. of Cardiology in Zabrze Medical University of Silesia; 🇵🇱 Zabrze, Upper Silesia, Poland