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Trial record 9 of 6679 for:    senior citizens

Frailty in Elderly Patients Receiving Cardiac Interventional Procedures (FRASER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02386124
Recruitment Status : Active, not recruiting
First Posted : March 11, 2015
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
Gianluca Campo, University Hospital of Ferrara

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.

Condition or disease Intervention/treatment Phase
Aged Other: frailty evaluation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Frailty Assessment in eldeRly Admitted to hoSpital for acutE caRdiac Disease Prospective Study
Actual Study Start Date : December 2014
Actual Primary Completion Date : October 31, 2017
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
frailty evaluation

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
assessment of mental and physical frailty before discharge from cardiac departement

Primary Outcome Measures :
  1. composite endpoint of all-cause mortality and all-cause hospital admission [ Time Frame: 1 year ]
    1-year cumulative incidence of all-cause mortality and all-cause hospital admission

Secondary Outcome Measures :
  1. all-cause mortality [ Time Frame: 1 year ]
    1-year cumulative incidence of death for all-causes

  2. hospital admission for all-causes [ Time Frame: 1 year ]
    1-year cumulative incidence of hospital admission for all causes

  3. cardiac adverse events [ Time Frame: 1 year ]
    1-year cumulative incidence of cardiac death, myocardial infarction, heart failure

Other Outcome Measures:
  1. cerebrovascular accident [ Time Frame: 1 year ]
    1-year cumulative incidence of stroke and/or transient ischemic attack

  2. admission in emergency room [ Time Frame: 1 year ]
    1-year cumulative incidence of admission in emergency room

  3. arrhythmias [ Time Frame: 1 year ]
    1-year cumulative incidence of new diagnosis of significant arrhythmias

  4. severe aortic stenosis [ Time Frame: 1 year ]
    1-year cumulative incidence of new diagnosis of severe aortic stenosis

  5. acute coronary syndrome (ACS) [ Time Frame: 1 year ]
    1-year cumulative incidence of new diagnosis of ACS (unstable angina and myocardial infarction)

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

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 identifier (NCT number): NCT02386124

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University Hospital of Ferrara
Cona, Ferrara, Italy, 44124
Sponsors and Collaborators
University Hospital of Ferrara
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Principal Investigator: Gianluca Campo, MD Azienda Ospedaliera Universitaria di Ferrara
Principal Investigator: Stefano Volpato, MD Azienda Ospedaliera Universitaria di Ferrara

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gianluca Campo, MD, University Hospital of Ferrara Identifier: NCT02386124     History of Changes
Other Study ID Numbers: 140994
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Gianluca Campo, University Hospital of Ferrara:
acute coronary syndrome
acute heart failure

Additional relevant MeSH terms:
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Pathologic Processes