Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Acute Coronary Syndrome Clinical Trial

— FRAPICA  

Official title:

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209414
• Other study ID #: Protocol ver. 1 08 May 2017
• Status: Recruiting
• Start date: May 17, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2023
• Source: Medical University of Silesia
• Contact: Andrzej R Tomasik, M.D. Ph.D., FESC
• Phone: 0048323732372
• Email: tomasik[@]poczta.onet.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• aged = 65

• symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI

• written, informed consent

Exclusion Criteria:

• lack of consent

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Frail Elderly Syndrome
• Frailty
• Heart Diseases
• Myocardial Ischemia
• Percutaneous Transluminal Coronary Angioplasty
• Syndrome

Locations

Country	Name	City	State
Poland	II Dept. of Cardiology in Zabrze Medical University of Silesia	Zabrze	Upper Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

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