Visit | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 Telephone interview | Visit 7 | Follow-up 1 year to 3 years (Visit 8, 9, 10, 11) |
Assessment | Baseline15 days~0 day | Angiogram 0 day | Discharge | 30 days±7 days | 90 days±7 days | 6 months±14 days | 1 year±30 days | 6 months intervals |
Informed consent | √ | |||||||
Inclusion/exclusion criteria check | √ | |||||||
History and physical examination | √ | |||||||
Vital signs* | √ | √ | √ | √ | √ | √ | ||
Blood laboratory test† and urine routine test | √ | √ | √ | √ | √ | |||
Coagulation function‡ | √ | |||||||
FBG, HbA1c§ | √ | √ | √ | √ | ||||
Platelet aggregation test and/or CYPC219 genotype test¶ | √ | |||||||
ECG | √ | |||||||
MRI/CT | √ | √ | ||||||
CTP** | √ | √ | √ | |||||
DSA/CTA/MRA | √ | √ | ||||||
Life-style modification review†† | √ | √ | √ | √ | √ | √ | √ | |
mRS | √ | √ | √ | √ | √ | √ | ||
NIHSS (neurological examination) examination) | √ | √ | √ | √ | ||||
EQ-5D | √ | √ | √ | |||||
MoCA¶ | √ | √ | √ | |||||
HR-VWI,TCD¶ | √ | √ | ||||||
Medication review and patient compliance survey | √ | √ | √ | √ | √ | |||
AE, SAE and endpoints‡‡ | √ | √ | √ | √ | √ | √ | √ | √ |
*Vital signs: body temperature, blood pressure, respiration rate, heart rate.
†Blood laboratory test includes blood routine and biochemistry examinations, hepatic and renal function tests.
‡Coagulation function: PT, APTT, TT, FIB, INR.
§HbA1c is an optional inspection but is recommended for patients with diabetes mellitus.
¶Platelet aggregation test, CYPC219 genotype test, MoCA, HR-VWI and TCD test are optional according to the actual situation of the centre.
**CTP is an optional inspection, but is recommended for patients with haemodynamic compromise, poor collateral or perforator stroke.
††Life-style modification review: including whether to smoke and the number of cigarettes per day; Weight: reflect the patient’s weight control through the patient’s weight and BMI; Exercise: number of exercises per week and duration of each exercise.
‡‡After 1 year of follow-up, follow-up will focus on AE, SAE and endpoint events;
AE, adverse event; CTA, CT angiography; CTP, CT perfusion; DSA, digital subtraction angiography; ECG, electrocardiograph; EQ-5D, quality-of-life EuroQol-5 Dimensions; FBG, fasting blood glucose; HbA1c, glycosylated haemoglobin; HR-VWI, high-resolution vessel wall imaging; INR, international normalized ratio; MoCA, montreal cognitive assessment; MRA, magnetic resonance angiography; mRS, modified Rankin scale; SAE, serious adverse event; TCD, transcranial Doppler.