Frailty Syndrome in Daily Practice of Interventional Cardiology Ward
NCT ID: NCT03209414
Last Updated: 2023-04-12
Study Results
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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RECRUITING
1000 participants
OBSERVATIONAL
2017-05-17
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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
* symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI
* written, informed consent
Exclusion Criteria
65 Years
ALL
No
Sponsors
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Medical University of Silesia
OTHER
Responsible Party
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Andrzej Tomasik MD PhD FESC
Assistant professor
Locations
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II Dept. of Cardiology in Zabrze Medical University of Silesia
Zabrze, Upper Silesia, Poland
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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Protocol ver. 1 08 May 2017
Identifier Type: -
Identifier Source: org_study_id
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