Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

NCT ID: NCT03209414

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-17

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* lack of consent
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Andrzej Tomasik MD PhD FESC

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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II Dept. of Cardiology in Zabrze Medical University of Silesia

Zabrze, Upper Silesia, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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

Role: CONTACT

0048323732372

Ewa Nowalany-Kozielska, Prof.

Role: CONTACT

0048323732372

Facility Contacts

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Beata Matyjaszczuk

Role: primary

0048323732372

Lidia Stankiewicz

Role: backup

0048323732372

References

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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.

Reference Type DERIVED
PMID: 32000408 (View on PubMed)

Other Identifiers

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Protocol ver. 1 08 May 2017

Identifier Type: -

Identifier Source: org_study_id

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