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Frailty in Vascular Patients Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT03668821
Recruitment Status : Unknown
Verified August 2019 by Imperial College London.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief Summary:
An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.

Condition or disease Intervention/treatment
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
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Frailty - An Observational Cohort Study
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between electronic Frailty Index and survival and complication rate. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients attending Vascular Surgery department for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation.
Criteria

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
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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): NCT03668821


Contacts
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Contact: Tristan R Lane, PhD FRCS 02033117317 tristan.lane@imperial.ac.uk

Locations
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United Kingdom
Imperial College London
London, United Kingdom, W6 8RF
Contact: Tristan R Lane, PhD FRCS       tristan.lane@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
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Study Chair: Alun H Davies, DM FRCS Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03668821    
Other Study ID Numbers: 18HH4445
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will be allowed to be shared on completion.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 3 years for 5 years
Access Criteria: Health researcher for non-commerical research

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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:
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Carotid Artery Diseases
Vascular Diseases
Peripheral Arterial Disease
Frailty
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
 Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases