EUCTR2012-000512-29-ES
Active, Not Recruiting
N/A
Sonothrombolysis potentiated by microbubbles as a novel treatment of acute ischemic stroke: a prospective randomized pilot study - SONOVUE
Institut de Recerca Hospital Sant Pau0 sitesApril 17, 2012
DrugsSONOVUE
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut de Recerca Hospital Sant Pau
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The main inclusion criteria will be:
- •\- 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\.9mg/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 ? 18 years
- •\-No significant improvement before treatment.
- •\-The treatment is initiated within 90 minutes of hospital admission (door\-to\-needle time ? 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\.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
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 \< 14 or previous Rankin scale score \>2 and NIHSS ? 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 exclusion criteria.
Outcomes
Primary Outcomes
Not specified
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