Frailty in Elderly Patients Receiving Cardiac Interventional Procedures (FRASER)
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|ClinicalTrials.gov Identifier: NCT02386124|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2015
Last Update Posted : April 17, 2019
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||402 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- all-cause mortality [ Time Frame: 1 year ]1-year cumulative incidence of death for all-causes
- hospital admission for all-causes [ Time Frame: 1 year ]1-year cumulative incidence of hospital admission for all causes
- cardiac adverse events [ Time Frame: 1 year ]1-year cumulative incidence of cardiac death, myocardial infarction, heart failure
- cerebrovascular accident [ Time Frame: 1 year ]1-year cumulative incidence of stroke and/or transient ischemic attack
- admission in emergency room [ Time Frame: 1 year ]1-year cumulative incidence of admission in emergency room
- arrhythmias [ Time Frame: 1 year ]1-year cumulative incidence of new diagnosis of significant arrhythmias
- severe aortic stenosis [ Time Frame: 1 year ]1-year cumulative incidence of new diagnosis of severe aortic stenosis
- acute coronary syndrome (ACS) [ Time Frame: 1 year ]1-year cumulative incidence of new diagnosis of ACS (unstable angina and myocardial infarction)
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): NCT02386124
|University Hospital of Ferrara|
|Cona, Ferrara, Italy, 44124|
|Principal Investigator:||Gianluca Campo, MD||Azienda Ospedaliera Universitaria di Ferrara|
|Principal Investigator:||Stefano Volpato, MD||Azienda Ospedaliera Universitaria di Ferrara|