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Recruiting NCT03209414

NCT03209414 Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

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Clinical Trial Summary
NCT ID NCT03209414
Status Recruiting
Phase
Sponsor Medical University of Silesia
Condition Frail Elderly Syndrome
Study Type OBSERVATIONAL
Enrollment 1,000 participants
Start Date 2017-05-17
Primary Completion 2024-12-31

Eligibility & Interventions

Sex All sexes
Min Age 65 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 1,000 participants in total. It began in 2017-05-17 with a primary completion date of 2024-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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

Contact & Investigator

Central Contact

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

✉ tomasik@poczta.onet.pl

📞 0048323732372

Frequently Asked Questions

Who can join the NCT03209414 clinical trial?

This trial is open to participants of all sexes, aged 65 Years or older, studying Frail Elderly Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03209414 currently recruiting?

Yes, NCT03209414 is actively recruiting participants. Contact the research team at tomasik@poczta.onet.pl for enrollment information.

Where is the NCT03209414 trial being conducted?

This trial is being conducted at Zabrze, Poland.

Who is sponsoring the NCT03209414 clinical trial?

NCT03209414 is sponsored by Medical University of Silesia. The trial plans to enroll 1,000 participants.

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