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The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program: rational and design of a multicenter prospective study

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Abstract

Background

Frailty has become a high-priority issue in cardiovascular medicine because of the aging of cardiovascular patients. Simple and reproducible tools to assess frailty in elderly patients are clearly on demand. Their application may help physicians in the selection of invasive and medical treatments and in the timing and modality of the follow-up. The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program is designed with the aim to validate the use of the short physical performance battery (SPPB) as prognostic tools in patients admitted to hospital for acute coronary syndrome (ACS).

Methods

The FRASER program is a multicenter prospective study involving 4 Italian cardiology units. The FRASER program enrolls only patients aged ≥70 years. The core of the FRASER program includes patients admitted to hospital for ACS. The aims are (1) to describe SPPB distribution before hospital discharge and (2) to investigate the prognostic role of SPPB score. The primary outcome is a composite of 1-year all-cause mortality and hospital readmission for any cause. Ancillary analyses will be focused on different study populations (patients hospitalized for arrhythmias or acute heart failure or symptomatic severe aortic stenosis) and on different tools to assess frailty (multidimensional prognostic index, clinical frailty score, grip strength).

Discussion

The FRASER program will fill critical gaps in the knowledge regarding the link between frailty, cardiovascular disease, interventional procedures and outcome and will help physicians in the generation of a more personalized risk assessment and in the identification of potential targets for interventions.

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Author information

Authors and Affiliations

  1. Cardiology Unit, Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Via Aldo Moro, 8, 44124, Cona, FE, Italy

    Gianluca Campo, Rita Pavasini, Elisabetta Tonet, Paolo Cimaglia, Giulia Scillitani, Giulia Bugani, Matteo Serenelli, Fatima Zaraket, Cristina Balla, Filippo Trevisan, Simone Biscaglia & Roberto Ferrari

  2. Laboratorio per le Tecnologie delle Terapie Avanzate (LTTA) Center, Ferrara, Italy

    Gianluca Campo & Roberto Ferrari

  3. Department of Medical Science, University of Ferrara, Ferrara, Italy

    Elisa Maietti & Stefano Volpato

  4. Division of Cardiology, Cento Hospital, Ferrara, Italy

    Biagio Sassone

  5. Unità Operativa di Cardiologia, Ospedale GB Morgagni, Forlì, Italy

    Marcello Galvani

  6. Maria Cecilia Hospital, GVM Care & Research, E.S.: Health Science Foundation, Cotignola, Italy

    Roberto Ferrari

Authors
  1. Gianluca Campo
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  2. Rita Pavasini
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  3. Elisa Maietti
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  4. Elisabetta Tonet
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  15. Roberto Ferrari
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  16. Stefano Volpato
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Corresponding author

Correspondence to Gianluca Campo.

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Conflict of interest

The authors report no relationships that could be construed as a conflict of interest.

Funding/support

The study was an investigator driven clinical trial conducted by the University of Ferrara.

Ethical approval

All procedures were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Ethics committee of the four participating institutions approved the protocol, and enrolled patients gave written informed consent before inclusion.

Statement of human and animal rights

This study was approved by the Ethical Review Committee of our hospital.

Informed consent

All participants will sign the consent at the time of the enrollment.

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Campo, G., Pavasini, R., Maietti, E. et al. The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program: rational and design of a multicenter prospective study. Aging Clin Exp Res 29, 895–903 (2017). https://doi.org/10.1007/s40520-016-0662-y

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  • DOI: https://doi.org/10.1007/s40520-016-0662-y

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