Frailty in Vascular Patients Undergoing Surgery

Peripheral Artery Disease Clinical Trial

Official title:

Vascular Frailty - An Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03668821
• Other study ID #: 18HH4445
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: February 2023
• Source: Imperial College London
• Contact: Tristan R Lane, PhD FRCS
• Phone: 02033117317
• Email: tristan.lane[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.

Description:

Vascular surgical operations are major procedures with significant associated morbidity and mortality. Frailty is a major factor influencing surgical outcome, but the effect on morbidity/mortality and quality of life is poorly understood in vascular surgery. Activity levels play a significant role in frailty and in pre-intervention preparation. It is anticipated that as frailty levels increase, activity levels decrease. It is hypothesised that vascular surgery patients suffer from a high prevalence of frailty and that increasing frailty will lead to increased morbidity and mortality and decreased quality of life.

This initial study will provide the foundations to identify targets for improvement in degree of frailty, appropriateness for surgery and outcome.

This project aims to:

Assess and quantify the prevalence of frailty as well as recording activity levels in the vascular surgery patient cohort Explore the impact of frailty and pre-op activity on surgical outcomes in the vascular surgical patient cohort to guide surgical treatments as well as future studies aimed at improving frailty and activity and thereby quality of life.

Identification of an appropriate metric of frailty for this population group to include activity, is a secondary aim of this proposal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All patients attending for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation under the care of the Vascular Surgery team

2. Willing and able to give informed written consent

Exclusion Criteria:

1. Those unable to give informed written consent

2. Those <18 years of age

3. In the opinion of the investigator unable or unwilling to comply with the requirements of the study

Related Conditions & MeSH terms

• Aneurysmal Disease
• Carotid Artery Diseases
• Frailty
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Vascular Diseases

Intervention

Other:
• Questionnaire
Quality of life and frailty questionnaires

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between electronic Frailty Index and survival and complication rate.	Survival and rate of complication correlated with the pre-operative frailty score (electronic Frailty Index).	6 months
Primary	Correlation between Q Mortality Index and survival and complication rate.	Survival and rate of complication correlated with the pre-operative frailty score (Q Mortality Index).	6 months
Primary	Correlation between ACS Risk Calculator Score and survival and complication rate.	Survival and rate of complication correlated with the pre-operative frailty score (ACS Risk Calculator).	6 months
Primary	Correlation between V-Possum and survival and complication rate.	Survival and rate of complication correlated with the pre-operative frailty score (V-Possum).	6 months
Secondary	Activity Levels Pre and Post Surgery as measured by the General Practice Physical Activity Questionnaire	General Practice Physical Activity Questionnaire will be used to assess patient reported activity before and after surgery.	6 months
Secondary	Quality of Life Pre and Post Surgery as measure by the EuroQoL EQ-5D questionnaire	EuroQol EQ-5D Quality of Life questionnaire will be used to assess patient reported quality of life before and after surgery.	6 months