Imaging requirements in ECST-2 National Hospital for Neurology and Neurosurgery, UCL  Imaging requirements in ECST-2 Ekaterina Biggs 23 March 2017

Baseline Imaging requirements All patients require brain and carotid imaging at baseline

Baseline Carotid Imaging Prior to randomisation all patients need to have two forms of carotid imaging to confirm the degree of stenosis, presence of ulceration and anatomical suitability for revascularisation This can include US and MRA, MRA and CTA or CTA and US

Baseline Carotid Imaging - timing Initial baseline carotid imaging - 120 days before randomisation up to the day of randomisation Confirmatory carotid imaging - 14 days before randomisation up to the day of randomisation

MR plaque imaging requirements Where available, additional imaging of the carotid plaque, e.g. MR plaque imaging will be performed and the results analysed in the central trial office to refine prediction of risk Please perform MR plaque imaging where possible by using basic or advanced protocols

Baseline brain imaging MRI using DWI and FLAIR sequences is much more sensitive than clinical assessment in detecting ischaemic brain lesions after carotid interventions and identifies cerebral infarction in patients without overt symptoms or signs Therefore, we screen patients at baseline and during follow up using MRI in ECST-2 to objectively determine rates of cerebral infarction and haemorrhage

Baseline brain imaging The baseline brain MRI is required to exclude other pathology, to identify existing infarcts and small vessel disease, and to provide a baseline reference against which any subsequent infarction or haemorrhage can be assessed The baseline and follow up images will be independently assessed by a neurologist and neuroradiologist blinded to treatment.

Baseline brain imaging All patients are required to have a baseline MRI brain. Sequences required: T1, T2, DWI, ADC, FLAIR, gradient echo T2* and/or SWI. If MR is contra-indicated1 (i.e. the patient has a pacemaker), or not available within a reasonable time period, brain CT should be done instead 1 If baseline MRI cannot be done before randomisation, but is not contra-indicated, do CT before randomisation and MRI as soon as possible after randomisation and before revascularisation

Baseline brain imaging - timing Baseline brain MRI: 14 days before randomisation up to day of randomisation in symptomatic stenosis 28 days before randomisation up to day of randomisation in asymptomatic stenosis

Baseline brain imaging - timing In exceptional cases where time pressure leads to trial centres experiencing problems performing an MRI before randomisation, patients may be randomised using a CT to exclude other pathology and an MRI performed after randomisation so long as this is done within 14 days of randomisation and before the scheduled time of revascularisation.

Follow up imaging brain One month MRI – optional MRI at 2 and 5 years Images will be assessed for any new brain lesions on follow up MRIs that were not present on the baseline MRI

Follow up imaging - Carotid ultrasound A follow up duplex ultrasound of the carotid stenosis on the randomised and the contralateral side will be carried out at the one month after revascularisation in those patients randomised to immediate revascularisation and at 6 weeks after randomisation in those allocated OMT alone. Carotid ultrasound will then be done annually after randomisation in both arms of the study

Carotid ultrasound reports Please try to anonymise all the imaging data. However, as a lot of centres recently had problems with the anonymisation of carotid ultrasounds images, we would like to confirm: We will accept carotid ultrasound images which are not anonymised!

Imaging data returns UCL patients: Imaging is being transferred from PACS to our central database Other centres: Imaging is returned to our central office on discs, and then are being uploaded to our central database

Monthly Reports We have been regularly producing and sending out monthly reports to our centres. We would like to ask you kindly to work with us and try to send all data to us frequently. Please return any outstanding data as soon as possible. If you have any problems with anything, please feel free to contact myself anytime.

Imaging reports Please send copies of MR and ultrasound reports together with the discs of all your randomised patients to the Central Office The reports will be stored in our database for any future analysis

Important data points Please ensure you send us anonymised imaging data, the right images and required sequences Everything you send to our Central Office is correctly labelled with the patients ECST-2 ID numbers and initials

Using carotid imaging for screening and the CAR score Use the ultrasound value for stenosis to screen patients in CAR score app If ultrasound not done, use CTA or MRA value Only answer yes to plaque ulceration if there is a definite ulcer reported on the imaging 

Thank you for your attention! Please return all the imaging data to: Stroke Research Group Institute of Neurology, UCL Box 6 NHNN Queen Square London WC1N 3BG Thank you for your attention!