Skip to content

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03209414
Acronym
FRAPICA
Enrollment
1000
Registered
2017-07-06
Start date
2017-05-17
Completion date
2027-12-31
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Frailty syndrome, Coronary heart disease, Coronary revascularization, Major adverse cardiovascular events, Arterial stiffness, Applanation tonometry, Lean body mass, ST2 biomarker

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.

Interventions

None listed

Sponsors

Medical University of Silesia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* lack of consent

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Incidence of contrast induced nephropathyUp to hospital discharge, on average day 4Number of patients with contrast induced nephropathy
Results of interventional treatmentUp to hospital discharge, on average day 4Number of patients with successful revascularization
Major cardiovascular events36 monthsNumber of cardiovascular deaths in long term follow-up
Incidence of bleedingUp to hospital discharge, on average day 4Number of patients with bleeding
Incidence of periprocedural infarctionUp to hospital discharge, on average day 4Number of patients with periprocedural infarction

Countries

Poland

Contacts

Primary ContactAndrzej R Tomasik, M.D. Ph.D., FESC
tomasik@poczta.onet.pl0048323732372
Backup ContactEwa Nowalany-Kozielska, Prof.
kl2karz@sum.edu.pl0048323732372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026