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Trial record 63 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward (FRAPICA)

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ClinicalTrials.gov Identifier: NCT03209414
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Andrzej Tomasik MD PhD FESC, Medical University of Silesia

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.


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

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Frailty Syndrome in Daily Practice of Interventional Cardiology Ward
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Group/Cohort
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Results of interventional treatment [ Time Frame: Up to hospital discharge, on average day 4 ]
    Number of patients with successful revascularization

  2. Incidence of periprocedural infarction [ Time Frame: Up to hospital discharge, on average day 4 ]
    Number of patients with periprocedural infarction

  3. Incidence of contrast induced nephropathy [ Time Frame: Up to hospital discharge, on average day 4 ]
    Number of patients with contrast induced nephropathy

  4. Incidence of bleeding [ Time Frame: Up to hospital discharge, on average day 4 ]
    Number of patients with bleeding

  5. Major cardiovascular events [ Time Frame: 36 months ]
    Number of cardiovascular deaths in long term follow-up

  6. Major cardiovascular events [ Time Frame: 36 months ]
    Number of all-cause deaths in long term follow-up

  7. Major cardiovascular events [ Time Frame: 36 months ]
    Number of patients with reinfarction in long term follow-up

  8. Major cardiovascular events [ Time Frame: 36 months ]
    Number of patients with target lesion revascularization in long term follow-up

  9. Major cardiovascular events [ Time Frame: 36 months ]
    Number of patients with stroke in long term follow-up

  10. Major cardiovascular events [ Time Frame: 36 months ]
    Number of patients with new onset heart failure in long term follow-up

  11. Major cardiovascular events [ Time Frame: 36 months ]
    Number of patients rehospitalized for any cause in long term follow-up


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.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209414


Contacts
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Contact: Andrzej R Tomasik, M.D. Ph.D., FESC 0048323732372 tomasik@poczta.onet.pl
Contact: Ewa Nowalany-Kozielska, Prof. 0048323732372 kl2karz@sum.edu.pl

Locations
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Poland
II Dept. of Cardiology in Zabrze Medical University of Silesia Recruiting
Zabrze, Upper Silesia, Poland, 41-800
Contact: Beata Matyjaszczuk    0048323732372    kl2karz@sum.edu.pl   
Contact: Lidia Stankiewicz    0048323732372    kl2karz@sum.edu.pl   
Principal Investigator: Andrzej R Tomasik, MD PhD FESC         
Sub-Investigator: Ewa Wołoszyn-Horak, MD         
Sub-Investigator: Robert Salamon, MD         
Sub-Investigator: Jakub Standera         
Sub-Investigator: Łukasz Bieda         
Sub-Investigator: Katarzyna Chojnacka         
Sub-Investigator: Aleksandra Brzosko         
Sub-Investigator: Ewa Nowalany-Kozielska, Prof         
Sponsors and Collaborators
Medical University of Silesia

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Responsible Party: Andrzej Tomasik MD PhD FESC, Assistant professor, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03209414     History of Changes
Other Study ID Numbers: Protocol ver. 1 08 May 2017
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrzej Tomasik MD PhD FESC, Medical University of Silesia:
Frailty syndrome
Coronary heart disease
Coronary revascularization
Major adverse cardiovascular events
Arterial stiffness
Applanation tonometry
Lean body mass
ST2 biomarker
Additional relevant MeSH terms:
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Heart Diseases
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Syndrome
Frailty
Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases