Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

August 29, 2016 updated by: Jonathan Afilalo, Jewish General Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • St. Boniface Hospital
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton General Hospital
      • Ottawa, Ontario, Canada
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada
        • Montreal Heart Institute
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada
        • Centre Hospitalier Universite de Montreal
  • France
      • Massy, France, 91300
        • Hôpital Jacques Cartier
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In-patients and out-patients referred for surgical or transcatheter aortic valve replacement.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Aortic valve replacement
Patients aged ≥70 years referred for surgical or transcatheter aortic valve replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of stay
Time Frame: 30 days
30 days
All-cause mortality
Time Frame: 6-12 months
6-12 months
Functional status
Time Frame: 6-12 months
6-12 months

Other Outcome Measures

Outcome Measure
Time Frame
Cognitive function
Time Frame: 6-12 months
6-12 months
Mood disturbance
Time Frame: 6-12 months
6-12 months
Delirium
Time Frame: 30 days
30 days
Disposition
Time Frame: 30 days
30 days
Readmission
Time Frame: 6-12 months
6-12 months
Cost analysis and resource use
Time Frame: 30 days
30 days
Echocardiographic function of ventricles and valves
Time Frame: 30 days
30 days
Longitudinal recovery of physical and cognitive functioning
Time Frame: Monthly (1-12 months)
Monthly (1-12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jewish General Hospital

Collaborators

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Duke University
Brigham and Women's Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre
McMaster University
Unity Health Toronto
St. Paul's Hospital, Canada
Ottawa Heart Institute Research Corporation
Montreal Heart Institute
Royal Victoria Hospital, Canada
St. Boniface Hospital
Hopital du Sacre-Coeur de Montreal

Investigators

  • Principal Investigator: Jonathan Afilalo, MD MSc, Jewish General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOP-123314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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