Clinical trial NCT01845207: Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
Official title: Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Cardiac Valve Replacement Complication
Fragility
Keywords: Aortic stenosis
Aortic valve replacement
Transcatheter aortic valve implantation
Outcomes
Frailty
Elderly
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Duke University
name: Hopital du Sacre-Coeur de Montreal
name: Massachusetts General Hospital
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: McMaster University
name: Montreal Heart Institute
name: Royal Victoria Hospital, Canada
name: St. Boniface Hospital
name: Unity Health Toronto
name: St. Paul's Hospital, Canada
name: Ottawa Heart Institute Research Corporation
First posted: 2013-05-03
Enrollment: 800
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-patients and out-patients referred for surgical or transcatheter aortic valve replacement.

Brief summary: Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years)
2. Severe AS
3. Referred for surgical or transcatheter AVR (with or without concomitant revascularization)
4. Signed informed consent

Exclusion Criteria:

1. Emergency surgery
2. Clinical instability: decompensated heart failure, active ischemia, unstable vital signs
3. Severe neuropsychiatric impairment
4. Not English or French speaking
5. Replacement of \>1 valve or aortic surgery

Primary outcomes:
measure: Post-procedural mortality or major morbidity
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 6-12 months
measure: Functional status
timeFrame: 6-12 months
measure: Length of stay
timeFrame: 30 days
Other outcomes:
measure: Cognitive function
timeFrame: 6-12 months
measure: Mood disturbance
timeFrame: 6-12 months
measure: Delirium
timeFrame: 30 days
measure: Disposition
timeFrame: 30 days
measure: Readmission
timeFrame: 6-12 months
measure: Cost analysis and resource use
timeFrame: 30 days
measure: Echocardiographic function of ventricles and valves
timeFrame: 30 days
measure: Longitudinal recovery of physical and cognitive functioning
timeFrame: Monthly (1-12 months)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Massy
country: France
facility: Hôpital Jacques Cartier
Study officials:
affiliation: Jewish General Hospital
name: Jonathan Afilalo, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi SM, Sung M, Afilalo J, Lipsitz LA, Kim CA, Popma JJ, Khabbaz KR, Laham RJ, Guibone K, Lee J, Marcantonio ER, Kim DH. Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement. J Am Geriatr Soc. 2019 Jul;67(7):1393-1401. doi: 10.1111/jgs.15867. Epub 2019 Mar 18.
citation: Afilalo J, Lauck S, Kim DH, Lefevre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Genereux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.