Sonothrombolysis Potentiated by Microbubbles for Acute Ischemic Stroke
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 31, 2012
CompletedFirst Posted
Study publicly available on registry
September 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 10, 2015
August 1, 2015
2.8 years
August 31, 2012
August 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Recanalization rate
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.
6 h, 24h, and day 90 post treatmente
Study Arms (2)
Sonothrombolysis + microbubbles
EXPERIMENTALrtPA+ sonovue. SonoVue sulphur hexafluoride microbubbles 8 microlitres/ml Powder and solvent for dispersion for injection 1 vial containing 25 mg lyophilized powder to be reconstituted with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection 1 pre-filled syringe containing sodium chloride 9 mg/ml (0.9%) solution for injection 1 Mini-Spike Plus 6/8 (CE 0123) transfer system. 1 ml of the reconstituted dispersion contains 8 microlitres sulphur hexafluoride microbubbles.
Standard intravenous thrombolysis
ACTIVE COMPARATORPatients in thecontrol group will use thehelmetbut without U.S continuous U.S wave emission. Serial monitoring of the status ofrecanalizationaccording to theschedule set will be carried out according to theestablished schedule
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Baseline blood glucose concentration less than 50 mg/dL or greater than 400 mg/dl, that cannot be corrected
- Uncontrolled hypertension, defined as systolic blood pressure \> 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2012
First Posted
September 5, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
August 10, 2015
Record last verified: 2015-08