Acute ischemic brain stroke
Conditions
Interventions
Trade Name: SONOVUE
Product Name: SONOVUE
Product Code: EU/1/01/177/002
Pharmaceutical Form: Powder and solvent for suspension for injection
CAS Number: 2551-62-4
Other descriptive name: SULFUR HEXAFL
Sponsors
Institut de Recerca Hospital Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The main inclusion criteria will be: - All acute (=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have 1 or more of the following: -severe stroke as indicated on baseline CT imaging or by a NIHSS score > 25 -evidence of hemorrhage on noncontrast head computed tomography CT), -any other standard contraindication for intravenous rtPA therapy, -primary treatment with intra-arterial thrombolysis, -Previous Rankin scale score > 1 and NIHSS 2 and NIHSS ? 14 - Rapidly improving neurological symptoms such that the rate of improvement is expected to result in a NIHSS score of 185 mm Hg or diastolic blood pressure >110 mm Hg on at least two separate occasions at least 10 min apart, or blood pressure that requires aggressive treatment to reduce it to within these limits - Hereditary or acquired hemorrhagic diathesis - Another stroke, a serious head injury or major surgery within the previous 3 month -Platelet count < 100.000/mm3 -Hemorrhagic retinopathy -Within 10 days of traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel -Bacterial endocarditis, pericarditis -Acute pancreatitis; documented ulcerative gastrointestinal disease during the last 3 months, esophageal varices -Arterial aneurysm, arterial/venous malformations -Neoplasm with increased bleeding risk -Severe liver disease, including hepatic failure, cirrhosis, portal hypertension and active hepatitis -Major surgery or significant trauma in past 3 months - Contraindication to CT perfusion: Iodinated contrast allergy, renal insufficiency (elevated serum creatinine above normal laboratory levels at each center), non-collaborative patients, pregnancy -Contraindication based on CT: Intracerebral or subarachnoid haemorrhage, arteriovenous malformation, cerebral aneurysm, tumour or non-ischaemic lesions mimicking stroke. Infarct core of more than 2/3 of middle cerebral artery territory or all of anterior cerebral artery territory. Any other contraindication to the imaging technique.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in a pilot study the safety and efficacy of common diagnostic sulfur hexafluorid MBs on the beginning, degree, and time to maximum completeness of middle cerebral artery (MCA) recanalization during systemic thrombolysis and continuous 2-Hz pulsed-wave TCD monitoring.;Secondary Objective: 1 To investigate whether the administration of ST plus MB treatment leads to an increase in the proportion of patients with MCA ischemic stroke that achieve an early clinical improvement (decrease in 4 or more points at at 24 h NIHSS) and good long-term functional outcome (Modified Rankin Scale 0-1 at 3 months), when compared to patients treated with standard treatment. 2 To assess the safety of ST plus MB treatment, in terms of mortality and of Hemorrhagic transformation rate (symptomatic and asymptomatic), within the first 3 month after treatment. Death from any cause will be recorded.;Primary end point(s): Recanalization rate - TIBI score;Timepoint(s) of evaluation of this end point: 1 hour and 6 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Short term clinical outcome Long term clinical outcome Mortality;Timepoint(s) of evaluation of this end point: 24 hours and 3 months | — |
Countries
Spain
Contacts
Public ContactRomy Rodríguez
Institut de Recerca Hospital sant Pau
Outcome results
None listed