Frail Elderly SyndromeFRAPICANCT03209414
Frailty Syndrome in Daily Practice of Interventional Cardiology Ward
An observational study of Frail Elderly Syndrome and Coronary Heart Disease, run by Medical University of Silesia at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Coronary Heart Disease, Acute Coronary Syndrome
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 17 May 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- aged ≥ 65
- symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI
- written, informed consent
Who cannot join
- lack of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
II Dept. of Cardiology in Zabrze Medical University of Silesia
Zabrze, Upper Silesia, 41-800
Beata Matyjaszczuk, 0048323732372, kl2karz@sum.edu.pl
Lidia Stankiewicz, 0048323732372, kl2karz@sum.edu.pl
About this study
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
- Medical subject headings
- Coronary Disease, Acute Coronary Syndrome, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale
Patients will be assessed with Fried frailty scale
Measured: 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
Measured: Up to hospital discharge, on average day 4
Secondary outcomes (11)
Results of interventional treatment
Number of patients with successful revascularization
Measured: Up to hospital discharge, on average day 4
Incidence of periprocedural infarction
Number of patients with periprocedural infarction
Measured: Up to hospital discharge, on average day 4
Incidence of contrast induced nephropathy
Number of patients with contrast induced nephropathy
Measured: Up to hospital discharge, on average day 4
Incidence of bleeding
Number of patients with bleeding
Measured: Up to hospital discharge, on average day 4
Major cardiovascular events
Number of cardiovascular deaths in long term follow-up
Measured: 36 months
Major cardiovascular events
Number of all-cause deaths in long term follow-up
Measured: 36 months
Major cardiovascular events
Number of patients with reinfarction in long term follow-up
Measured: 36 months
Major cardiovascular events
Number of patients with target lesion revascularization in long term follow-up
Measured: 36 months
Major cardiovascular events
Number of patients with stroke in long term follow-up
Measured: 36 months
Major cardiovascular events
Number of patients with new onset heart failure in long term follow-up
Measured: 36 months
Major cardiovascular events
Number of patients rehospitalized for any cause in long term follow-up
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start17 May 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrzej Tomasik MD PhD FESC, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209414
- Sponsor's protocol ID
- Protocol ver. 1 08 May 2017
- Acronym
- FRAPICA
- Status last verified
- Apr 2023
- First submitted
- 24 Jun 2017
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32000408
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Syndrome in Daily Practice of Interventional Cardiology Ward
- ClinicalTrials.gov ID
- NCT03209414
- Acronym / sponsor ID
- FRAPICA / Protocol ver. 1 08 May 2017
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- aged ≥ 65
- symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI
- written, informed consent
Key exclusion criteria (1 listed)
- lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
11 secondary outcomes
Results of interventional treatment
Time frame: Up to hospital discharge, on average day 4
Incidence of periprocedural infarction
Time frame: Up to hospital discharge, on average day 4
Incidence of contrast induced nephropathy
Time frame: Up to hospital discharge, on average day 4
Incidence of bleeding
Time frame: Up to hospital discharge, on average day 4
Major cardiovascular events
Time frame: 36 months
Major cardiovascular events
Time frame: 36 months
Major cardiovascular events
Time frame: 36 months
Major cardiovascular events
Time frame: 36 months
Major cardiovascular events
Time frame: 36 months
Major cardiovascular events
Time frame: 36 months
Major cardiovascular events
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 32000408Woloszyn-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome and Coronary Heart Disease, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrzej R Tomasik, M.D. Ph.D., FESC (0048323732372, tomasik@poczta.onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predischarge distribution of frailty syndrome according to Fried phenotype frailty scale (time frame: Up to hospital discharge, on average day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.