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Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01845207
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : August 31, 2016
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Duke University
Hopital du Sacre-Coeur de Montreal
Massachusetts General Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre
McMaster University
Montreal Heart Institute
Royal Victoria Hospital, Canada
St. Boniface Hospital
Unity Health Toronto
St. Paul's Hospital, Canada
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
Jonathan Afilalo, Jewish General Hospital

Study Description
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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.

Condition or disease
Aortic Stenosis Cardiac Valve Replacement Complication Fragility

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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) ]

Biospecimen Retention:   Samples Without DNA
Tissue specimens

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In-patients and out-patients referred for surgical or transcatheter aortic valve replacement.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845207


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Centre Hospitalier Universite de Montreal
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
France
Hôpital Jacques Cartier
Massy, France, 91300
Sponsors and Collaborators
Jewish General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Duke University
Hopital du Sacre-Coeur de Montreal
Massachusetts General Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre
McMaster University
Montreal Heart Institute
Royal Victoria Hospital, Canada
St. Boniface Hospital
Unity Health Toronto
St. Paul's Hospital, Canada
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Jonathan Afilalo, MD MSc Jewish General Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jonathan Afilalo, MD MSc FACC FRCPC, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01845207    
Other Study ID Numbers: MOP-123314
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Keywords provided by Jonathan Afilalo, Jewish General Hospital:
Aortic stenosis
Aortic valve replacement
Transcatheter aortic valve implantation
 Outcomes
Frailty
Elderly
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Frailty
Pathologic Processes
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction