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Visual study on the clinical mechanism of edaravone dexborneol on immune inflammation after ischemic stroke based on PET/MRI imaging of neuroinflammation

Visual study on the clinical mechanism of edaravone dexborneol on immune inflammation after ischemic stroke based on PET/MRI imaging of neuroinflammation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048153
Enrollment
Unknown
Registered
2021-07-04
Start date
2021-07-05
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Interventions

Experimental group:Standard treatment + edaravone dexborneol
Control group:Standard treatment + normal saline

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 85 years; 2. Within 48 hours after the onset of acute ischemic stroke; The onset time of symptoms was defined as "the last time that seemed normal"; 3. The patients with partial anterior circulation cerebral infarction of OCSP type could be observed by MRI; 4. Baseline NIHSS 1 to 16; 5. The subjects or their guardians voluntarily participated and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. CT or MRI showed intracranial hemorrhage (SWI microbleeds excluded); 2. History of severe central nervous system damage (such as tumor, aneurysm or arteriovenous malformation, craniocerebral trauma, intracranial or spinal cord surgery, etc.); 3. Immune related diseases (Guillain Barre syndrome, neuromyelitis optical, multiple sclerosis, Parkinson's disease, myasthenia gravis and other systemic immune diseases); 4. Infection events occurred within one week before and after enrollment; 5. Severe liver diseases, including liver failure, cirrhosis, portal hypertension, esophageal varices and active hepatitis; 6. Major operation or severe trauma in recent 2 weeks; 7. Aortic dissection; 8. The subjects had serious, fatal and disabled diseases, and the expected survival time was less than 3 months; 9. Known to have dementia or mental illness, unable to complete neurological assessment and follow-up; 10. Pregnancy or lactation or positive pregnancy test; 11. Participated in clinical trials of other drugs or devices within three months; 12. It is judged by the researcher that it is not suitable to participate in this study or it may cause the subjects to face greater risks; 13. Patients who need thrombolysis, thrombectomy or CAS or CEA.

Design outcomes

Primary

MeasureTime frame
positron emission tomography / computedtomography-normalized uptake value;

Secondary

MeasureTime frame
Modified Rankin Rating Scale at 90 days;National Institute of Health stroke scale at 90 days;infarct core volume in MR DWI/T2 flair;electroencephalogram;Inflammatory factor in blood;Incidence of stroke at 90 days;

Countries

China

Contacts

Public ContactHuang Li'an

The First Affiliated Hospital of Jinan University

huanglian1306@126.com+86 20 38688637

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026