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Completed

NCT Number: NCT01845207

Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

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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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiac Valve Replacement Complication Cardiovascular Diseases Fragility Frailty Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul's Hospital, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years)
  • Severe AS
  • 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

Treatment and study plan

Primary outcomes

  1. 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

  1. All-cause mortality

    Time frame: 6-12 months

  2. Functional status

    Time frame: 6-12 months

  3. Length of stay

    Time frame: 30 days

Other outcomes

  1. Cognitive function

    Time frame: 6-12 months

  2. Mood disturbance

    Time frame: 6-12 months

  3. Delirium

    Time frame: 30 days

  4. Disposition

    Time frame: 30 days

  5. Readmission

    Time frame: 6-12 months

  6. Cost analysis and resource use

    Time frame: 30 days

  7. Echocardiographic function of ventricles and valves

    Time frame: 30 days

  8. Longitudinal recovery of physical and cognitive functioning

    Time frame: Monthly (1-12 months)

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
  • Duke University
  • Massachusetts General Hospital
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • McMaster University
  • Montreal Heart Institute
  • Ottawa Heart Institute Research Corporation
  • Royal Victoria Hospital, Canada
  • St. Boniface Hospital
  • St. Paul's Hospital, Canada
  • Unity Health Toronto

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
May 3, 2013
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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