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Clinical trial of magnetic induction electrical impedance tomography in screening severe hemorrhagic stroke auxiliarily

Clinical trial of magnetic induction electrical impedance tomography in screening severe hemorrhagic stroke auxiliarily

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070131
Enrollment
Unknown
Registered
2023-04-03
Start date
2022-08-23
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Acute stage of stroke

Interventions

Gold Standard:CT or MR scan of the head
Index test:Cranial vascular imaging(including CTA?MRA and DSA)?Scoring table of NIHSS?Thrombus Load Score

Sponsors

SIR RUN RUN SHAW HOSPITAL ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 18 years old or above, male or female; 2)After the examination of CT and or MR, diagnosis of acute stroke in clinic; 3)It is expected that the test equipment can be safely worn for more than 5 minutes; 4)The Informed Consent Form has been signed.

Exclusion criteria

Exclusion criteria: 1)The head and neck are provided with implantable electrical stimulation devices; 2)There are large metal implants in the craniofacial region, such as bone fixation plates, meshes, etc. (small metal objects can be grouped, such as aneurysm coils); 3)Intracranial pressure detection and other devices affect the placement of test equipment; 4)Circumstances where the test equipment should not be used, such as scalp lesions, previous intracranial surgery, etc; 5)Women in lactation and pregnancy; 6)Those with severe combined injuries or hemorrhagic shock; 7)People with epilepsy or poisoning symptoms; 8)severe restlessness which will effect the study; 9) Head circumference > 60cm, unable to apply test equipment; 10)Mental illness; 11)The researcher believes that it is not appropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
The sensitivity and specificity of magnetic induction brain electrical impedance tomography to assist in identifying severe hemorrhagic stroke.;

Secondary

MeasureTime frame
Area under the ROC curve AUC to assist in identifying hemorrhagic stroke in stroke patients;The sensitivity and specificity of assisting in identifying the type of stroke ischemia or hemorrhage in stroke patients;;The sensitivity and specificity of NIHSS score in distinguishing severe hemorrhagic stroke among stroke patients, and the correlation coefficient with MBA;Correlation coefficient between thrombus load score and MBA in patients with ischemic large vessel occlusion stroke;Instrument fault evaluation;

Countries

China

Contacts

Public ContactYirong Wang

No. 3, Qingchun East Road, Shangcheng District, Hangzhou, Zhejiang

zhangbiyan55@163.com+86 13805725319

Outcome results

None listed

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