Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Aortic Stenosis Clinical Trial

Official title:

Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845207
• Other study ID #: MOP-123314
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: August 29, 2016
• Start date: January 2012
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: March 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Cardiac Valve Replacement Complication
• Constriction, Pathologic
• Fragility

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Centre Hospitalier Universite de Montreal	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba
France	Hôpital Jacques Cartier	Massy
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (14)

Lead Sponsor

Collaborator

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 Center, McMaster University, Montreal Heart Institute, Ottawa Heart Institute Research Corporation, Royal Victoria Hospital, Canada, St. Boniface General Hospital Research Centre, St. Michael's Hospital, Toronto, St. Paul's Hospital, Canada

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function		6-12 months	No
Other	Mood disturbance		6-12 months	No
Other	Delirium		30 days	No
Other	Disposition		30 days	No
Other	Readmission		6-12 months	No
Other	Cost analysis and resource use		30 days	No
Other	Echocardiographic function of ventricles and valves		30 days	No
Other	Longitudinal recovery of physical and cognitive functioning		Monthly (1-12 months)	No
Primary	Post-procedural mortality or major morbidity	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	No
Secondary	All-cause mortality		6-12 months	No
Secondary	Functional status		6-12 months	No
Secondary	Length of stay		30 days	No