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NCT Number: NCT03209414

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

II Dept. of Cardiology in Zabrze Medical University of Silesia

Zabrze, Upper Silesia, 41-800, Poland

Location status: Recruiting

Location contact

Aleksandra Brzosko

SUB_INVESTIGATOR

Andrzej R Tomasik, MD PhD FESC

PRINCIPAL_INVESTIGATOR

Beata Matyjaszczuk

CONTACT

[email protected]

0048323732372

Ewa Nowalany-Kozielska, Prof

SUB_INVESTIGATOR

Ewa Wołoszyn-Horak, MD

SUB_INVESTIGATOR

Jakub Standera

SUB_INVESTIGATOR

Katarzyna Chojnacka

SUB_INVESTIGATOR

Lidia Stankiewicz

CONTACT

[email protected]

0048323732372

Robert Salamon, MD

SUB_INVESTIGATOR

Łukasz Bieda

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • lack of consent

Treatment and study plan

Primary outcomes

  1. Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale

    Time frame: Up to hospital discharge, on average day 4

    Patients will be assessed with Fried frailty scale

  2. Predischarge distribution of frailty syndrome according to instrumental activities of daily living scale

    Time frame: Up to hospital discharge, on average day 4

    Patients will be assessed with instrumental activities of daily living scale

Secondary outcomes

  1. Results of interventional treatment

    Time frame: Up to hospital discharge, on average day 4

    Number of patients with successful revascularization

  2. Incidence of periprocedural infarction

    Time frame: Up to hospital discharge, on average day 4

    Number of patients with periprocedural infarction

  3. Incidence of contrast induced nephropathy

    Time frame: Up to hospital discharge, on average day 4

    Number of patients with contrast induced nephropathy

  4. Incidence of bleeding

    Time frame: Up to hospital discharge, on average day 4

    Number of patients with bleeding

  5. Major cardiovascular events

    Time frame: 36 months

    Number of cardiovascular deaths in long term follow-up

  6. Major cardiovascular events

    Time frame: 36 months

    Number of all-cause deaths in long term follow-up

  7. Major cardiovascular events

    Time frame: 36 months

    Number of patients with reinfarction in long term follow-up

  8. Major cardiovascular events

    Time frame: 36 months

    Number of patients with target lesion revascularization in long term follow-up

  9. Major cardiovascular events

    Time frame: 36 months

    Number of patients with stroke in long term follow-up

  10. Major cardiovascular events

    Time frame: 36 months

    Number of patients with new onset heart failure in long term follow-up

  11. Major cardiovascular events

    Time frame: 36 months

    Number of patients rehospitalized for any cause in long term follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Andrzej R Tomasik, M.D. Ph.D., FESC

CONTACT

[email protected]

0048323732372

Ewa Nowalany-Kozielska, Prof.

CONTACT

[email protected]

0048323732372

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Acronym: FRAPICA

Important dates

Study start
2017
Primary completion
2024
Study completion
2027
First posted
Jul 6, 2017
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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