Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05897645
Other study ID # Y(2022)070
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 19, 2023
Est. completion date January 2026

Study information

Verified date June 2023
Source General Hospital of Shenyang Military Region
Contact HuiSheng
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Intracranial atherosclerotic disease is the most common cause of ischemic stroke in Asia, also in China. Currently, despite vascular recanalization therapy, statins are one of the main drug choices for treating atherosclerotic plaque. High resolution magnetic resonance imaging (HRMRI) can accurately assess the status of intracranial and extracranial arterial plaque, and has high consistency with histopathology. Thus, HRMRI technology has been widely used to monitor the efficacy of drug treatment for atherosclerotic plaque in clinical trials or practice. As a non-invasive technique, HRMRI make it possible to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery in vivo. It can quantitative analysis including components such as lipid-rich necrotic core, fiber cap thickness, intra-plaque hemorrhage, calcification, etc. Therefore, it is crucial for evaluating the etiology of ischemic stroke and developing secondary prevention strategies. At present, there is a lack of large-scale and prospective study to evaluate the etiology of ischemic stroke including cryptogenic stroke based on HRMRI. In this context, this study aims to establish a multi center HRMRI database of intracranial arteries among Chinese patients with ischemic stroke.


Recruitment information / eligibility

Status Recruiting
Enrollment 2110
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - 1. Patient age =40 years - 2. Time of stroke onset: within 2 week - 3. Baseline NIHSS score =16 - 4. Ischemic stroke confirmed by head CT or MRI - 5. Premorbid mRS =1 - 6. The degree of stenosis of extracranial arteries including internal carotid artery, vertebral artery on the lesion side =50% - 7. The culprit plaque or possible culprit plaque with plaque burden of 40% or more found by HRMRI in the proximal part of the middle cerebral artery M1 segment or basilar artery of ipsilateral lesion - 8. Signed informed consent Exclusion Criteria: - 1. Intracranial hemorrhage found by head CT - 2. Had a contraindication to MRI,or could not complete required MRI sequences - 3. Intracranial tumor, arteriovenous malformation, or aneurysm - 4. Comorbidity with any serious diseases and life expectancy is less than one year - 5. Pregnancy - 6. Patients not suitable for this clinical studies considered by researcher

Study Design


Intervention

Other:
Registration
collect clinical date, assess the morphologic characteristics of plaque

Locations

Country Name City State
China Department of Neurology, General Hospital of Northern Theater Command Shenyang

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of stroke including ischemic or hemorrhagic stroke 360 days
Secondary Recurrence of stroke including ischemic or hemorrhagic stroke 90 days, 180 days
Secondary the composite events of cardiovascular events Cardiovascular events include cardiovascular death, stroke, non-fatal myocardial infarction, and arterial revascularization 90 days, 180 days, 360 days
Secondary distribution of modified Rankin Scale (mRS) score mRS score range from 0 to 6: 0 [no symptoms] to 6 [death] 90 days, 180 days 360 days
Secondary The relationship between characteristics of intracranial plaques and functional independence characteristics of intracranial plaques includes plaque composition, location and morphology; functional independence is defined as modified Rankin Scale (mRS) score 0-1 (mRS score range from 0 to 6: 0 [no symptoms] to 6 [death]) 90 days, 180 days, 360 days
Secondary The relationship between burden of cerebral small vessel disease and functional independence burden of cerebral small vessel disease ranges from 0 to 4, with higher scores indicating greater burden; functional independence is defined as modified Rankin Scale (mRS) score 0-1 (mRS score range from 0 to 6: 0 [no symptoms] to 6 [death]) 90 days, 180 days, 360 days
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A