Table 3 Outline of baseline and follow-up appointments including investigations required and target time window
Visit/follow-up | Investigations | Target time window |
|---|---|---|
Baseline | Brain MRI | 14 days in symptomatic stenosis or 28 days in asymptomatic stenosis before or after randomisation, done before any revascularisation procedure |
Initial carotid imaging | 120 days before randomisation up to the day of randomisation | |
Confirmatory second carotid imaging | 14 days before randomisation up to the day of randomisation | |
Clinical assessment, blood pressure Baseline blood lipids and glucose, serum troponin levels ECG MoCA, EQ-5D, RFA | 14 days before randomisation up to the day of randomisation | |
Post-procedure visit in revascularised patients only | Clinical assessment, blood pressure Troponin and ECG | Day of treatment +48 h ±24 h |
4–6 weeks post-randomisation | Clinical assessment, blood pressure MoCA, EQ-5D, RFA | Day of treatment +30 days ±7 days in revascularised patients |
ECG and troponin in the OMT arm | Day of randomisation +42 days ±7 days in OMT only patients | |
Carotid ultrasound in revascularised patients | Day of treatment +30 days ±7 days | |
Brain MRI (optional) | Day of treatment +30 days ±7 days in revascularised patients Day of randomisation +42 days ±7days in OMT only patients | |
3 months post-randomisation | Telephone follow-up | Day of randomisation +90 days ±14 days |
6 months post-randomisation | Clinical assessment, blood pressure EQ-5D, RFA Fasting lipids and glucose | Day of randomisation +180 days ±14 days |
Annual follow-up | Clinical assessment, blood pressure EQ-5D, RFA Fasting lipids and glucose Carotid ultrasound MoCA and brain MRI at 2 and 5 years | Day of randomisation +X years ±1 month |
Bi-annual telephone follow-up | Telephone follow-ups between annual follow-ups | Day of randomisation +X years +6 months ±1 month |