Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Stenosis Cardiac Valve Replacement Complication Fragility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic valve replacement

Patients aged ≥70 years referred for surgical or transcatheter aortic valve replacement.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No