An observational study in Vascular Diseases, Carotid Artery Diseases and Aneurysmal Disease, sponsored by Imperial College London. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Imperial College London · Observational
An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.
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.
248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.
This study's planned enrollment of 300 is above the median of 224 across 108 observational studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Consecutive patients attending Vascular Surgery department for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation.
Exclusion Criteria:
Patients with Carotid Artery Disease. Quality of life and frailty questionnaires
Other: Questionnaire
Patients with Aneurysmal Disease. Quality of life and frailty questionnaires
Other: Questionnaire
Patients with Peripheral Artery Disease. Quality of life and frailty questionnaires
Other: Questionnaire
Quality of life and frailty questionnaires
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 6 months
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.
Time frame: 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.
Time frame: 6 months
Plan to share: Yes — Anonymised data will be allowed to be shared on completion.
Supporting information: Study protocol, Icf, Csr
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Imperial College London