Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
Completed
Conditions studied: Aortic Stenosis, Cardiac Valve Replacement Complication, Fragility
In brief
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.
Key facts
- Study ID
- NCT01845207
- Run by
- Jewish General Hospital
- People needed
- 800
- Starts
- 2012-01-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-08-31
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years)
- Severe AS
- Referred for surgical or transcatheter AVR (with or without concomitant revascularization)
- Signed informed consent
You may not qualify if…
- Emergency surgery
- Clinical instability: decompensated heart failure, active ischemia, unstable vital signs
- Severe neuropsychiatric impairment
- Not English or French speaking
- Replacement of >1 valve or aortic surgery
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Duke University Medical Center — Durham, North Carolina, United States
- St. Paul's Hospital — Vancouver, British Columbia, Canada
- St. Boniface Hospital — Winnipeg, Manitoba, Canada
- Hamilton General Hospital — Hamilton, Ontario, Canada
- Ottawa Heart Institute — Ottawa, Ontario, Canada
- St. Michael's Hospital — Toronto, Ontario, Canada
- Jewish General Hospital — Montreal, Quebec, Canada
- Centre Hospitalier Universite de Montreal — Montreal, Quebec, Canada
- Montreal Heart Institute — Montreal, Quebec, Canada
- Royal Victoria Hospital — Montreal, Quebec, Canada
- Hôpital Jacques Cartier — Massy, France
Full record on ClinicalTrials.gov
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