Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT04962295
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old
2. SVD lesions can be seen on MRI of the head
* White matter hyperintensity, Fazekas score ≥ 2
* Fazekas=1 has more than 2 vascular risk factors (hypertension, hyperlipidemia, diabetes, obesity, smoking, and other vascular events except stroke).
* Fazekas = 1 and combined with lacunar focus
* Imaging findings suggest new subcortical lacunar infarction
3. Daily life independence (MRS ≤ 2)
4. Sign informed consent
Note: the imaging definition of small vessel disease refers to the strong guideline
1. The total score of Fazekas was 6, which was the sum of Fazekas scores of subcortical and periventricular white matter lesions.
2. New subcortical lacunar infarction: head MRI examination, subcortical, basal ganglia or brain stem DWI showed high signal (ADC diffusion limited) lesions with diameter \< 20 mm, with or without corresponding clinical symptoms; There were new clinical symptoms. FLAIR sequence of head MRI showed flair hyperintense lesions (diameter \< 20 mm) in subcortical, basal ganglia or pons.
Exclusion Criteria:
1. In acute cerebral infarction, the lesions showed high signal intensity on DWI, and the diameter was more than 20 mm
2. Acute cerebral hemorrhage
3. Acute subarachnoid hemorrhage, or previous history of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage,
Or untreated aneurysms (\> 3mm in diameter) were found
4. Neurodegenerative diseases, such as AD and PD, have been diagnosed
5. There are clear non angiogenic white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy
Diseases, etc
6. Mental disorders diagnosed according to DSM-V diagnostic criteria
7. Contraindications of MRI examination (such as claustrophobia)
8. With severe organic diseases, such as malignant tumor, the expected survival time is less than 5 years
9. Due to geographical or other reasons can not cooperate to complete the follow-up
10. Patients also participated in other clinical trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04962295
Study Brief:
Protocol Section:
NCT04962295