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A case records based study of reevaluate the safety and efficacy of multi-mode CT imaging to intravenous thrombolysis in acute ischemic stroke patients (CT-ACTION)

A case records based study of reevaluate the safety and efficacy of multi-mode CT imaging to intravenous thrombolysis in acute ischemic stroke patients (CT-ACTION)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014368
Enrollment
Unknown
Registered
2018-01-09
Start date
2018-01-10
Completion date
Unknown
Last updated
2018-01-15

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

Conditions

acute ischemic stroke

Interventions

Sponsors

the Third people's Hospital of Dalian
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. the clinical diagnosis is ischemic stroke which can cause the assessment of neurological impairment (such as language, motor function, cognitive impairment, gaze disorder, visual field defect or/and visual neglect). Ischemic stroke is defined as a sudden acute focal neurological deficit, presumably caused by cerebral ischemia, and CT excludes bleeding; 3. the new stroke symptoms or signs from the onset to the treatment is within the time window of 3-9 hours; 4. the first onset or previous stroke without obvious sequelae (mRS = 2); 5. patient's symptoms conform to the thrombolytic therapy and the main evaluation index can be collected. Image presentations: (1) patient does not conform toexclusion criteria of CT plain sweeping; (2) the original image of CTA showed an abnormal low density area involving over than 2cm of the diameter of the cerebral hemisphere, and the area of the abnormal low density area was greater than 1/3 of the arear of MCA; (3) the abnormal perfusion area of CTP was greater than 20% area of the abnormal low density of CTA original image; (4) CTA showed that TICI was graded at grade 0 or 1 (large vessel occlusion or severe stenosis).

Exclusion criteria

Exclusion criteria: 1. previous stroke with significant sequelae (mRS>2); 2. severe stroke are confirmed by coma or clinical assessment (such as NIHSS>25) or/and other imaging findings; 3. there was a history of stroke in 3 months; 4. the use of heparin within 48 hours before the onset of the disease, and aPTT exceeded the upper limit of the normal value of the laboratory; 5. the value of creatinine is beyond the normal range (>133 umol/L); 6. platelet count 185mmHg or diastolic>110mmHg measured at intervals of at least 10 minutes and repeated 3 times; 8. blood glucose400mg/dl(22.2mmol/l); 9. there are significant hemorrhagic diseases in the present or past 6 months; 10. patients were treated with oral anticoagulants (such as warfarin),;INR>1.5; 11. there are intracranial hemorrhage history or suspected intracranial hemorrhage (including subarachnoid hemorrhage); 12. pregnancy or lactation; 13. a history of severe central nervous system damage (such as tumors, aneurysms, intracranial or spinal operations); 14. hemorrhagic retinopathy, such as diabetes (visual impairment may indicate retinal hemorrhage) or other hemorrhagic eye lesions; 15. bacterial endocarditis and pericarditis; 16. prolonged or traumatic cardiopulmonary resuscitation (>2min), parturition in the last 10 days or recent non pressure vessels (subclavian vein or jugular vein); 17. acute pancreatitis; 18. confirmed ulcerative gastrointestinal disease (within 3 months); 19. aneurysm or arteriovenous malformation; 20. with a tumor that may increase the risk of bleeding; 21. serious liver diseases, including liver failure, liver cirrhosis, portal hypertension (varicose esophagus), active hepatitis; 22. there was a major or severe trauma, and a history of craniocerebral trauma for the last ten days; 23. anaphylaxis drug allergy. Image presentations: (1) cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intracranial tumor (2) contraindication of imaging examination (3) high density hemorrhagic shadows at any part and at any degree of the brain on CT. (4) an obvious occupying sign because of the middle line displacement caused by large area cerebral infarction. (5) low density shadow and superficial blurring exist beyond the 1/3 range of the middle cerebral artery distribution area or the cerebral parenchyma in suspected infarct.

Design outcomes

Primary

MeasureTime frame
The changes of nerve function defect score (NIHSS) at 7 days or at discharge compared with the baseline;

Secondary

MeasureTime frame
Incidence of hemorrhagic events after thrombolytic therapy;The changes of 2h and 24-36h of nerve function defect score (NIHSS) after thrombolytic treatment compared with the baseline;mRS score of 90 days after treatment;mRS score of 1 year after treatment;The proportion of adverse events and dead patients at 90 days after treatment;The degree of stenosis and the change of infarct size in the imaging guidance of patients at 7 days or at the time of discharge from the baseline;

Countries

China

Contacts

Public ContactZhang Jingbo

the Third people's Hospital of Dalian

13942647790@163.com+86 13942647790

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026