Status:
TERMINATED
Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S)
Lead Sponsor:
Umeå University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients with acute ischemic stroke in anterior circulation within 4,5 hours of symptom onset, has a bone window and Trombolysis In Brain Ischemia (TIBI) \<=4 in a relevant artery eligible. Both patie...
Eligibility Criteria
Inclusion
- Male or female patients ≥18 years with acute ischaemic stroke in the anterior circulation, who has given written consent for his/her participation to the study.
- Remaining neurological deficit that is ≥1 NIHSS points, sufficient to warrant treatment with tPA (not taking possible contraindications into account) and is severe enough that possible improvement is clearly analysable
- Treatment \<4½ hours of symptom onset or of waking up in the morning with symptoms
- Sufficient bone window for acceptable or better acquisition of flow information with ultrasound with TIBI ≤ 4 in the symptomatic artery
- In cases with women of Childbearing Capacity (WOCBC): Only if willing to comply with effective contraception methods during the course of the trial. Acceptable methods are such as oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double-barrier methods (for example, condom and spermicide), intrauterine device (IUD), hormonal IUD
Exclusion
- Patients with premorbid modified Rankin Scale (mRS) score ≥3;
- Patients for whom a complete NIHSS cannot be obtained;
- Hemiplegic migraine with no arterial occlusion on baseline Computed Tomography of brain (CT);
- Seizure at stroke onset and no visible occlusion on baseline CT;
- Intracranial haemorrhage on baseline CT;
- Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal;
- Large areas of hypodense ischaemic changes on baseline CT;
- Pregnancy or breast-feeding, pericarditis; sepsis; any other serious medical illness likely to interact with treatment; confounding pre-existent neurological or psychiatric disease; unlikely to complete follow-up; any investigational drug \<14 days;
- Inability to provide informed consent sufficiently clearly that the study physician can be convinced that informed consent has been given by the patient - such as severe aphasia or coma.
- Specific sonothrombolysis exclusion criteria
- known hypersensitivity/allergy to SonoVue;
- recent or unstable coronary ischemia or resting angina \<7 days;
- acute cardiac insufficiency, cardiac insufficiency class III/IV; serious cardiac arrhythmias;
- any right-left-shunt; severe pulmonary hypertension; uncontrolled hypertension;
- moderate to severe Chronic Obstructive Pulmonary Disease (COPD; baseline O2 saturation \<80%);
- acute respiratory distress syndrome (ARDS);
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03290053
Start Date
November 28 2017
End Date
April 18 2018
Last Update
May 11 2018
Active Locations (1)
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1
University Hospital
Umeå, Västerbotten County, Sweden, 90821