Evaluating the risk of macrovascular events, disability, and mortality in individuals with multiple sclerosis in England: a population-based retrospective cohort study

Study type
Protocol
Date of Approval
Study reference ID
18_279
Lay Summary

Multiple sclerosis (MS) is a disabling disease of the central nervous system affecting more than 120,000 people in the UK. As compared with the general population, individuals with MS have an increased risk of cardiovascular disease (a general term referring to conditions affecting the heart and blood vessels), because they are more likely to have elevated blood pressure and blood lipids, and to be obese, which are all risk factors for cardiovascular disease. Evaluating the cardiovascular risk of individuals with MS is therefore important, considering that increased cardiovascular risk in individuals with MS is also associated with more rapid disease progression and increased risk of death.

This projects aims to improve our understanding of the association between cardiovascular risk factors, occurrence of major cardiovascular events (stroke and heart attack), and risk of disability in MS. Specifically, the projects has the objective to evaluate whether the risk of major cardiovascular events in individuals with MS differs from the general population. The project also has an additional objective that consists in developing and validating a clinical tool to predict the risk of MS-related disability and major cardiovascular events for individuals with MS, suitable to be used by general practitioners and nurses when examining individuals with MS.

Technical Summary

Cardiovascular risk assessment and management is important in individuals with multiple sclerosis (MS) considering they have high prevalence of cardiovascular risk factors, have increased risk of macrovascular complications, and cardiovascular risk factors are associated with more rapid disease progression and higher mortality.
This project aims to conduct a population-based retrospective cohort study of individuals with MS matched to controls by age, sex, and general practice to i) assess whether in the UK the risk of macrovascular events and cardiovascular mortality differs in individuals with MS as compared with the general population; ii) identify predictors of macrovascular events and disability in MS; iii) develop and validate a risk score to predict the risk of MS-related disability and macrovascular disease suitable for use in primary care settings.
Multivariable survival hazard models will be employed to assess whether incident rates of macrovascular events differ between individuals with MS and the control population. Specifically, for individuals with MS, a risk prediction algorithm will be developed for each of the following outcomes: occurrence of acute coronary events, occurrence of cerebrovascular events, use of cane, and use of wheelchair. Internal validation of the risk prediction algorithm will be performed using the k-fold method.

Health Outcomes to be Measured

Acute coronary events (acute myocardial infarction, coronary artery disease, coronary revascularisation procedures)
- Cerebrovascular disease (haemorrhagic and ischaemic stroke)
- Use of cane
- Use o wheelchair

Collaborators

Jeremy Chataway - Chief Investigator - University College London ( UCL )
Raffaele Palladino - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Mekha Mathew - Collaborator - Imperial College London
Ruth Anne Marrie - Collaborator - University of Manitoba

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Practice Level Index of Multiple Deprivation