Sonothrombolysis Potentiated by Microbubbles for Acute Ischemic Stroke

NCT ID: NCT01678495

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-07-31

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.

Conditions

Cerebrovascular Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sonothrombolysis + microbubbles

rtPA+ 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.

Group Type: EXPERIMENTAL

Sulfur hexafluoride + ultrasounds

Intervention Type: OTHER

Recombinant tissue plasminogen activator

Intervention Type: DRUG

Standard intravenous thrombolysis

Patients 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

Group Type: ACTIVE_COMPARATOR

Recombinant tissue plasminogen activator

Intervention Type: DRUG

Interventions

Sulfur hexafluoride + ultrasounds

Intervention Type: OTHER

Recombinant tissue plasminogen activator

Intervention Type: DRUG

Eligibility Criteria

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
• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

IIBSP-SPM-2011-63

Identifier Type: -

Identifier Source: org_study_id