ACST-1 follow-up study of memory and thinking function

• Research type

  Research Study

• Full title

  Does surgery for asymptomatic carotid stenosis reduce the long term risk of dementia, stroke, death and other important health outcomes? Extended UK post-trial follow-up of the Asymptomatic Carotid Surgery Trial (ACST-1). Phase 2

• IRAS ID

  261069

• Contact name

  Alison Halliday

• Contact email

  alison.halliday@nds.ox.ac.uk

• Sponsor organisation

  University of Oxford

• ISRCTN Number

  ISRCTN26156392

• Duration of Study in the UK

  0 years, 6 months, 30 days

• Research summary

  People with narrowing of their carotid artery (an important blood vessel in the neck) are at higher long-term risk of stroke, and there is some suggestion that they are also at higher risk of dementia. We know that an operation to remove tight narrowing in the carotid artery (carotid endarterectomy) reduces the risk of stroke, but we do not know whether it reduces the risk of dementia.
  ACST-1 was a large, publicly funded, international trial that randomly allocated participants with tight narrowing of the carotid artery to either immediate carotid surgery (endarterectomy) or to avoid surgery unless they had symptoms. The trial found that endarterectomy reduced the risk of stroke by 5 years and for at least 10 years after the operation.

  If we find that endarterectomy for carotid stenosis reduces risk of dementia, this would be important, because treatment of carotid narrowing for this indication is not currently used in the NHS. A reduction in the risk of dementia would alter the risks and benefits of surgery, and provide better information to patients and clinicians.

  To answer this question we are conducting a post-trial, long-term follow-up study of 1601 UK and Swedish participants from ACST-1. The follow-up includes:
  1) Data linkage with National electronic health records. This is now complete.
  
  2) Assessment using the validated, short 'Informant Questionnaire on Cognitive Decline in the Elderly' (IQCODE) in living ACST-1 participants (UK only) to measure any changes in memory & thinking (cognition).
  The 'informant' would be a nominated relative or friend of the ACST-1 participant who would complete the IQCODE questionnaire, by telephone, with the Study Coordinator (registered nurse).

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  19/SC/0149

• Date of REC Opinion

  23 Apr 2019

• REC opinion

  Favourable Opinion