Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

NCT03209414 | Recruiting DMC

• 1 other identifier: Protocol ver. 1 08 May 2017
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Frailty syndrome; Coronary heart disease; Coronary revascularization; Major adverse cardiovascular events; Arterial stiffness; Applanation tonometry; Lean body mass; ST2 biomarker

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Results of interventional treatment

  Up to hospital discharge, on average day 4

• Incidence of periprocedural infarction

  Up to hospital discharge, on average day 4

• Incidence of contrast induced nephropathy

  Up to hospital discharge, on average day 4

• Incidence of bleeding

  Up to hospital discharge, on average day 4

• Major cardiovascular events

  36 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• lack of consent

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

II Dept. of Cardiology in Zabrze Medical University of Silesia

Zabrze, Upper Silesia, 41-800, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 32000408 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

4 ml of blood plasma is frozen at -80 degrees of Celsius. SST2 will be assayed after completion of recruitment.

MeSH Terms

Conditions

Coronary Disease; Acute Coronary Syndrome; Frailty

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

0048323732372; tomasik@poczta.onet.pl

Ewa Nowalany-Kozielska, Prof.

CONTACT

0048323732372; kl2karz@sum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: July 6, 2017
• Study Start: May 17, 2017
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

PL (1)