Frailty in Elderly Patients Receiving Cardiac Interventional Procedures

NCT02386124 | Completed DMC

• 1 other identifier: 140994
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50 years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%, respectively, due to more effective therapies and lower mortality of many diseases. Yet, chronic diseases are nowadays more important, and often coexist as comorbidity or multimorbidity, depending on whether an index condition has been considered. These conditions increase the risk of death and reduce functional autonomy in the elderly and, therefore, should be carefully considered within comprehensive geriatric assessment. The epidemiology of cardiovascular disease, as demonstrated among others by the Oxford Vascular Study, shows a clear trend in age-dependent, as the number of events and their incidence increases with age, and about half are concentrates over 75 years. In addition, some observational studies in elderly patients have suggested an association between frailty and cardiovascular disease: fragility and cardiovascular disease share a common biological pathway, and cardiovascular diseases may accelerate the onset of frailty. The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease, according to the rating scale used and the population studied. Frail patients with cardiovascular disease, in particular those undergoing invasive procedures or suffering from coronary artery disease and aortic valve disease, have a much higher adverse events and complications, suggesting the need for a more accurate functional stratification and a more careful evaluation of the risk/benefit ratio of some invasive procedures. Among the numerous tests proposed in the literature for the functional evaluation and objective measures of physical capability in elderly patient, the Short Physical Performance Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those characterized by an improved prognostic ability and an easy administration. The present study is performed to assess if SPPB and handgrip are helpful to better stratify the prognosis (all-causes death and hospital admission for all causes) in elderly patients admitted to hospital for cardiac causes.

Conditions

Aged

Keywords

frailty; elderly; acute coronary syndrome; acute heart failure; arrhythmias

Outcome Measures

Primary Outcomes (1)

• composite endpoint of all-cause mortality and all-cause hospital admission

  1-year cumulative incidence of all-cause mortality and all-cause hospital admission

  1 year

Secondary Outcomes (3)

• all-cause mortality

  1 year

• hospital admission for all-causes

  1 year

• cardiac adverse events

  1 year

Other Outcomes (5)

• cerebrovascular accident

  1 year

• admission in emergency room

  1 year

• arrhythmias

  1 year

Study Arms (1)

frailty evaluation

OTHER

all consecutive patients admitted to hospital for acute cardiac disease aged more than 69 years will be evaluated with Short Portable Mental Status Questionnaire (SPMSQ), handgrip and Short Physical Performance Battery (SPPB). These three tests (SPMSQ, SPPB and handgrip) are the intervention of the study. They are the assays to establish the frailty status

Other: frailty evaluation

Interventions

frailty evaluation OTHER

assessment of mental and physical frailty before discharge from cardiac departement

frailty evaluation

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥70
• hospital admission in the cardiac department for acute cardiac disease (acute coronary syndromes, acute heart failure, arrhythmias requiring pace-maker or implantable cardioverter-defibrillator)

You may not qualify if:

• SPMSQ value ≤4
• inability to stay upright
• life expectancy \<3 months

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Related Publications (4)

• Campo G, Pavasini R, Maietti E, Tonet E, Cimaglia P, Scillitani G, Bugani G, Serenelli M, Zaraket F, Balla C, Trevisan F, Biscaglia S, Sassone B, Galvani M, Ferrari R, Volpato S. The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program: rational and design of a multicenter prospective study. Aging Clin Exp Res. 2017 Oct;29(5):895-903. doi: 10.1007/s40520-016-0662-y. Epub 2016 Oct 28.

  PMID: 27796963 BACKGROUND

• Balla C, Passarini G, Bonsi B, Pavasini R, Tonet E, Malagu M, Campo G, Bertini M. Physical performance status predicts mortality in aging patients undergoing pacemaker implantation. J Cardiovasc Med (Hagerstown). 2021 Oct 1;22(10):738-743. doi: 10.2459/JCM.0000000000001209.

  PMID: 33973534 DERIVED

• Pavasini R, Maietti E, Tonet E, Bugani G, Tebaldi M, Biscaglia S, Cimaglia P, Serenelli M, Ruggiero R, Vitali F, Galvani M, Minarelli M, Rubboli A, Bernucci D, Volpato S, Campo G. Bleeding Risk Scores and Scales of Frailty for the Prediction of Haemorrhagic Events in Older Adults with Acute Coronary Syndrome: Insights from the FRASER study. Cardiovasc Drugs Ther. 2019 Oct;33(5):523-532. doi: 10.1007/s10557-019-06911-y.

  PMID: 31549262 DERIVED

• Campo G, Maietti E, Tonet E, Biscaglia S, Ariza-Sole A, Pavasini R, Tebaldi M, Cimaglia P, Bugani G, Serenelli M, Ruggiero R, Vitali F, Formiga F, Sanchis J, Galvani M, Minarelli M, Lucchi GR, Ferrari R, Guralnik J, Volpato S. The Assessment of Scales of Frailty and Physical Performance Improves Prediction of Major Adverse Cardiac Events in Older Adults with Acute Coronary Syndrome. J Gerontol A Biol Sci Med Sci. 2020 May 22;75(6):1113-1119. doi: 10.1093/gerona/glz123.

  PMID: 31075167 DERIVED

MeSH Terms

Conditions

Frailty; Acute Coronary Syndrome; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Gianluca Campo, MD

  Azienda Ospedaliera Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

• Stefano Volpato, MD

  Azienda Ospedaliera Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: December 1, 2014
• Primary Completion: October 31, 2017
• Study Completion: April 28, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

IT (1)