Clinical trial NCT03209414: Frailty Syndrome in Daily Practice of Interventional Cardiology Ward
Official title: Frailty Syndrome in Daily Practice of Interventional Cardiology Ward
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frail Elderly Syndrome
Coronary Heart Disease
Acute Coronary Syndrome
Coronary Artery Bypass Grafting
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
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators assume to enroll consecutive 1000 patients with symptomatic coronary artery disease admitted to 2nd Dept. of Cardiology in Zabrze, Medical University of Silesia for coronary angiography or interventional treatment of the disease. Patients of both sexes aged ≥ 65 years are eligible. An information on study rationale, objectives, and methodology is presented to patients and written, informed consent is required to participate in the study.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* lack of consent

Primary outcomes:
measure: Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale
timeFrame: Up to hospital discharge, on average day 4
measure: Predischarge distribution of frailty syndrome according to instrumental activities of daily living scale
timeFrame: Up to hospital discharge, on average day 4
Secondary outcomes:
measure: Results of interventional treatment
timeFrame: Up to hospital discharge, on average day 4
measure: Incidence of periprocedural infarction
timeFrame: Up to hospital discharge, on average day 4
measure: Incidence of contrast induced nephropathy
timeFrame: Up to hospital discharge, on average day 4
measure: Incidence of bleeding
timeFrame: Up to hospital discharge, on average day 4
measure: Major cardiovascular events
timeFrame: 36 months
measure: Major cardiovascular events
timeFrame: 36 months
measure: Major cardiovascular events
timeFrame: 36 months
measure: Major cardiovascular events
timeFrame: 36 months
measure: Major cardiovascular events
timeFrame: 36 months
measure: Major cardiovascular events
timeFrame: 36 months
measure: Major cardiovascular events
timeFrame: 36 months
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: II Dept. of Cardiology in Zabrze Medical University of Silesia
state: Upper Silesia
Study officials:
References:
citation: Woloszyn-Horak E, Salamon R, Chojnacka K, Brzosko A, Bieda L, Standera J, Ploszaj K, Stepien E, Nowalany-Kozielska E, Tomasik A. Frailty syndrome in daily practice of interventional cardiology ward-rationale and design of the FRAPICA trial: A STROBE-compliant prospective observational study. Medicine (Baltimore). 2020 Jan;99(5):e18935. doi: 10.1097/MD.0000000000018935.