Frailty in Vascular Patients Undergoing Surgery

Vascular Frailty - An Observational Cohort Study

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

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Carotid Artery Diseases; Peripheral Artery Disease; Aneurysmal Disease
• Intervention / Treatment: Other: Questionnaire

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Tristan R Lane, PhD FRCS; Phone Number: 02033117317; Email: tristan.lane@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W68RF
    • Recruiting
    • Imperial College Healthcare NHS Trust
    • Contact: Majd Rawashdeh; Email: mr2812@ic.ac.uk
  • London, United Kingdom, W6 8RF
    • Not yet recruiting
    • Imperial College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients attending Vascular Surgery department for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carotid Artery Disease; Patients with Carotid Artery Disease. Quality of life and frailty questionnaires	Other: Questionnaire; Quality of life and frailty questionnaires
Aneurysmal Disease; Patients with Aneurysmal Disease. Quality of life and frailty questionnaires	Other: Questionnaire; Quality of life and frailty questionnaires
Peripheral Artery Disease; Patients with Peripheral Artery Disease. Quality of life and frailty questionnaires	Other: Questionnaire; Quality of life and frailty questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Imperial College Healthcare NHS Trust
• Investigators: Study Chair: Alun H Davies, DM FRCS, Imperial College London

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2024
• Study Completion (ANTICIPATED): October 1, 2025

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (ACTUAL): September 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Vascular Diseases; Peripheral Artery Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Vascular Diseases; Peripheral Arterial Disease; Frailty; Carotid Artery Diseases
• Other Study ID Numbers: 18HH4445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be allowed to be shared on completion.
• IPD Sharing Time Frame: 3 years for 5 years
• IPD Sharing Access Criteria: Health researcher for non-commerical research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No