Cerebrovascular Stroke
Conditions
Brief summary
It has proposed the use of ST without microbubble treatment in randomized association with both intravenous and intra-arterial thrombolysis, but combined treatment (rtPA + U.S.) associated with MB diagnostic not yet been investigated in a randomized study. The aim of this study is to evaluate efficacy of the combined treatment (r-rtPA+US+MB) vs the standard rtPA treatment in a randomized study in consecutive patients with acute ischemic stroke. We expect to demonstrate that the combined treatment (rtPA+US+MB) will be statistically superior to standard treatment in terms of recanalization rate.
Interventions
OTHERSulfur hexafluoride + ultrasounds
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All acute (\<4,5 hours) ischemic stroke patients in the MCA territory (as depicted by head computed tomography CT or suspected by clinical data) with a disabling neurological deficit measurable by National Institute of Health Stroke Scale (NIHSS) score, that in the opinion of treating physicians require and meet accepted criteria of treatment with a standard 0.9 mg/kg dose of iv rtPA. * A documented occlusion of the middle cerebral artery (MCA) documented by TCD and/or angioCT. * The patient or the legal representative signs the written consent to participate * Age \> or = 18 years * No significant improvement before treatment. * The treatment is initiated within 90 minutes of hospital admission (door-to-needle time \< or = 90 minutes) * There is no limitation regarding the NIHSS score. Scores under 5 are usually considered mild strokes, but they can be treated if the investigator believes that the measured deficit is important enough to cause disability. The investigator should weight benefits and risks when the score is under 5 and above 22.
Exclusion criteria
* 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 \< 14 or previous Rankin scale score \> 2 and NIHSS \> or = 14 * Rapidly improving neurological symptoms such that the rate of improvement is expected to result in a NIHSS score of \< 4 at randomization * Coexisting neurological diseases such as dementia or life-threatening illness. * Seizure at symptom onset * History or clinical presentation of intracranial hemorrhage, subarachnoid hemorrhage (even with a normal CT), arteriovenous malformation, aneurysm, spinal cord disease or cerebral neoplasm. Incidental meningioma and microbleeds per se are not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recanalization rate | 6 h, 24h, and day 90 post treatmente | The short term efficacy of treatment will be evaluated by recanalization rate at 6 hours control TCD (TIBI score) and at 24 hours by the NIHSS (a \> 4 points improvement). As explained, the Rankin scale score will be used to test the efficacy of the treatment at day 90 after stroke onset. |
Countries
Spain
Outcome results
None listed