Frailty in Vascular Patients Undergoing Surgery

• Sponsor: Imperial College London (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03668821
• Collaborator: Imperial College Healthcare NHS Trust (Other)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases; Carotid Artery Diseases; Aneurysmal Disease; Peripheral Artery Disease	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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Vascular Frailty - An Observational Cohort Study
• Anticipated Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Correlation between electronic Frailty Index and survival and complication rate. [6 months]

   Survival and rate of complication correlated with the pre-operative frailty score (electronic Frailty Index).

2. Correlation between Q Mortality Index and survival and complication rate. [6 months]

   Survival and rate of complication correlated with the pre-operative frailty score (Q Mortality Index).

3. Correlation between ACS Risk Calculator Score and survival and complication rate. [6 months]

   Survival and rate of complication correlated with the pre-operative frailty score (ACS Risk Calculator).

4. Correlation between V-Possum and survival and complication rate. [6 months]

   Survival and rate of complication correlated with the pre-operative frailty score (V-Possum).

Secondary Outcome Measures

1. Activity Levels Pre and Post Surgery as measured by the General Practice Physical Activity Questionnaire [6 months]

   General Practice Physical Activity Questionnaire will be used to assess patient reported activity before and after surgery.

2. Quality of Life Pre and Post Surgery as measure by the EuroQoL EQ-5D questionnaire [6 months]

   EuroQol EQ-5D Quality of Life questionnaire will be used to assess patient reported quality of life before and after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College London	London		United Kingdom	W6 8RF

Sponsors and Collaborators

• Imperial College London
• Imperial College Healthcare NHS Trust

Investigators

• Study Chair: Alun H Davies, DM FRCS, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT03668821
• Other Study ID Numbers: 18HH4445
• First Posted: Sep 13, 2018
• Last Update Posted: Aug 20, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Vascular Diseases; Peripheral Artery Disease
• Additional relevant MeSH terms: Carotid Artery Diseases; Vascular Diseases; Peripheral Arterial Disease; Frailty

Study Results

No Results Posted as of Aug 20, 2019