Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

NCT01845207 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2016-08-31

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis
  • Cardiac Valve Replacement Complication
  • Fragility

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER
  • Brigham and Women's Hospital

    collaborator OTHER
  • Duke University

    collaborator OTHER
  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    collaborator OTHER
  • Massachusetts General Hospital

    collaborator OTHER
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER
  • McMaster University

    collaborator OTHER
  • Montreal Heart Institute

    collaborator OTHER
  • Royal Victoria Hospital, Canada

    collaborator OTHER
  • St. Boniface Hospital

    collaborator OTHER
  • Unity Health Toronto

    collaborator OTHER
  • St. Paul's Hospital, Canada

    collaborator OTHER
  • Ottawa Heart Institute Research Corporation

    collaborator OTHER
  • Jewish General Hospital

    lead OTHER

Principal Investigators

  • Jonathan Afilalo, MD MSc · Jewish General Hospital

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-12-31
Completion
2016-03-31

Countries

  • United States
  • Canada
  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01845207 on ClinicalTrials.gov