Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Completed

• Conditions: Aortic Stenosis; Cardiac Valve Replacement Complication; Fragility

• Registration Number: NCT01845207
• Lead Sponsor: Jewish General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-03
• Primary Completion: 2014-12
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-procedural mortality or major morbidity	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 Outcome Measures

Name	Time	Method
All-cause mortality	6-12 months
Length of stay	30 days
Functional status	6-12 months

Trial Locations

Locations (14)

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Centre Hospitalier Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

Hôpital Jacques Cartier; 🇫🇷 Massy, France

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada