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Study on the key technology of reperfusion therapy and the improvement of first aid process in acute ischemic stroke

Study on the key technology of reperfusion therapy and the improvement of first aid process in acute ischemic stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048903
Enrollment
Unknown
Registered
2021-07-19
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

acute ischemic stroke

Interventions

case series:Reperfusion treatment

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Acute ischemic stroke; 3. NIHSS score >=4 points at the time of enrollment; 4. Intracranial artery occlusion (TIMI grade 0-1): internal carotid artery (T/L), middle cerebral artery M1/M2 segment, anterior cerebral artery A1/A2 segment, basilar artery, vertebral artery; 5. Plan reperfusion therapy including intravenous thrombolysis, arterial thrombolysis, mechanical thrombectomy, angioplasty, etc.; 6. The patient or the patient's legal representative is able and willing to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The mRS score before the stroke was >1; 2. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc.; 3. History of coagulation disorders, systemic bleeding, thrombocytopenia or neutropenia; 4. Chronic liver disease, liver and kidney insufficiency, elevated ALT (more than 3 times the upper limit of normal), elevated serum creatinine (more than 2 times the upper limit of normal); 5. Those with serious cardiopulmonary diseases, the researchers believe that they are not suitable to participate in this study; 6. Patients with life expectancy less than 3 months or unable to complete the study for other reasons; 7. DSA examination is contraindicated, severe contrast medium allergy or iodine contrast medium is absolutely contraindicated; 8. Patients of childbearing age, pregnant or breastfeeding women who have a negative pregnancy test but refuse to take effective contraceptive measures; 9. Unable to complete the researcher due to mental illness, cognitive or emotional disorder; 10. Patients who are considered by other researchers to be unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Onset-reperfusion time;Functional independence (defined as Mrs<= 2) or functional improvement (mRS rank variable analysis) at 90 days;Proportion of serious adverse events occurring within 90±7 days of treatment;

Secondary

MeasureTime frame
Time from onset to hospital admission;Admission - opening Hours;Admission-imaging time;Imaging-puncture time;Puncture-opening time;Changes of NIHSS score immediately after reperfusion;Changes of NIHSS score 24 ± 3 hours after reperfusion;Arterial recanalization ratio 24 +/- 3 hours after reperfusion;Changes of cerebral infarction volume on plain CT scan 24 +/- 3 hours after reperfusion;Changes of NIHSS score 7 days after reperfusion or at discharge;Changes of NIHSS at 90 +/- 7 days;Quality of life at 90 +/- 7 days;The proportion of symptomatic bleeding within 90 +/- 7 days of treatmen;The proportion of all-cause death within 90 +/- 7 days of treatment;Proportion of adverse events within 90 +/- 7 days of treatment;Proportion of serious adverse events within 14 days of treatment;Proportion of all-cause death within 14 days of treatment;Proportion of adverse events within 14 days of treatment;

Countries

China

Contacts

Public ContactWu Wei

Qilu Hospital of Shandong University

drwuwei@126.com+86 18560082121

Outcome results

None listed

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