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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Poland
  • Upper Silesia
    • Zabrze, Upper Silesia, Poland, 41-800
      • Recruiting
      • II Dept. of Cardiology in Zabrze Medical University of Silesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Stable coronary artery disease; 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; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: June 24, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Coronary heart disease; Arterial stiffness; Coronary revascularization; Frailty syndrome; Applanation tonometry; Major adverse cardiovascular events; Lean body mass; ST2 biomarker
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Syndrome; Frailty; Acute Coronary Syndrome
• Other Study ID Numbers: Protocol ver. 1 08 May 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No