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Clinical Trials/NCT01845207
NCT01845207
Completed
N/A

Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Jewish General Hospital14 sites in 3 countries800 target enrollmentJanuary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aortic Stenosis
Sponsor
Jewish General Hospital
Enrollment
800
Locations
14
Primary Endpoint
Post-procedural mortality or major morbidity
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
March 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan Afilalo

MD MSc FACC FRCPC

Jewish General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years)
  • Referred for surgical or transcatheter AVR (with or without concomitant revascularization)
  • Signed informed consent

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Post-procedural mortality or major morbidity

Time Frame: 30 days

Mortality is defined as death from any cause. Major morbidity is defined as an aggregate of the Society of Thoracic Surgeons (STS) and Valve Academic Research Consortium (VARC) composite endpoints. Additionally, the individual components of this composite endpoint will be examined.

Secondary Outcomes

  • All-cause mortality(6-12 months)
  • Length of stay(30 days)
  • Functional status(6-12 months)

Study Sites (14)

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