Vascular DiseasesNCT03668821
Frailty in Vascular Patients Undergoing Surgery
An observational study of Vascular Diseases and Carotid Artery Diseases, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Carotid Artery Diseases, Aneurysmal Disease
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jan 2021to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients attending Vascular Surgery department for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation.
Who may be able to join
- All patients attending for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation under the care of the Vascular Surgery team
- Willing and able to give informed written consent
Who cannot join
- Those unable to give informed written consent
- Those <18 years of age
- In the opinion of the investigator unable or unwilling to comply with the requirements of the study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Imperial College London
London, W6 8RF
Tristan R Lane, PhD FRCS, tristan.lane@imperial.ac.uk
- Recruiting
Imperial College Healthcare NHS Trust
London, W68RF
Majd Rawashdeh, mr2812@ic.ac.uk
About this study
Official title: Vascular Frailty - An Observational Cohort Study
An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.
Read the 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.
- Being tested
- Questionnaire
- Keywords
- Vascular Diseases, Peripheral Artery Disease
- Medical subject headings
- Vascular Diseases, Carotid Artery Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Quality of life and frailty questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Carotid Artery Disease | Patients with Carotid Artery Disease. Quality of life and frailty questionnaires Receives: Other: Questionnaire | |
| Aneurysmal Disease | Patients with Aneurysmal Disease. Quality of life and frailty questionnaires Receives: Other: Questionnaire | |
| Peripheral Artery Disease | Patients with Peripheral Artery Disease. Quality of life and frailty questionnaires Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Jan 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, DM FRCS, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668821
- Sponsor's protocol ID
- 18HH4445
- Status last verified
- Feb 2023
- First submitted
- 4 Sep 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be allowed to be shared on completion.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Frailty - An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03668821
- Acronym / sponsor ID
- 18HH4445
- Keywords
- Vascular Diseases, Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carotid Artery Disease | – | Other: QuestionnairePatients with Carotid Artery Disease. Quality of life and frailty questionnaires |
| Aneurysmal Disease | – | Other: QuestionnairePatients with Aneurysmal Disease. Quality of life and frailty questionnaires |
| Peripheral Artery Disease | – | Other: QuestionnairePatients with Peripheral Artery Disease. Quality of life and frailty questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients attending Vascular Surgery department for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation.
Key inclusion criteria (2 listed)
- All patients attending for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation under the care of the Vascular Surgery team
- Willing and able to give informed written consent
Key exclusion criteria (3 listed)
- Those unable to give informed written consent
- Those <18 years of age
- In the opinion of the investigator unable or unwilling to comply with the requirements of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuality of life and frailty questionnaires | Other | Aneurysmal Disease, Carotid Artery Disease, Peripheral Artery Disease |
Primary outcome
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).
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).
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).
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).
2 secondary outcomes
Activity Levels Pre and Post Surgery as measured by the General Practice Physical Activity Questionnaire
Time frame: 6 months
Quality of Life Pre and Post Surgery as measure by the EuroQoL EQ-5D questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes. Anonymised data will be allowed to be shared on completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun H Davies, DM FRCS study chair
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases and Carotid Artery Diseases, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tristan R Lane, PhD FRCS (02033117317, tristan.lane@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between electronic Frailty Index and survival and complication rate. (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.