Sonothrombolysis Potentiated by Microbubbles for Acute Ischemic Stroke

This study is currently recruiting participants.
Verified August 2012 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01678495
First received: August 31, 2012
Last updated: January 23, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Stroke
Other: Sulfur hexafluoride + ultrasounds
Drug: Recombinant tissue plasminogen activator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Sonothrombolysis Potentiated by Microbubbles as a Novel Treatment of Acute Ischemic Stroke: a Prospective Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Recanalization rate [ Time Frame: 6 h, 24h, and day 90 post treatmente ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Other: Sulfur hexafluoride + ultrasounds Drug: Recombinant tissue plasminogen activator
Active Comparator: 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
Drug: Recombinant tissue plasminogen activator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678495

Contacts
Contact: Lavinia Dinia, MD ldinia@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Lavinia Dinia, MD       ldinia@santpau.cat   
Principal Investigator: Joan Marti, MD         
Principal Investigator: Lavinia Dinia, MD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01678495     History of Changes
Other Study ID Numbers: IIBSP-SPM-2011-63
Study First Received: August 31, 2012
Last Updated: January 23, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on April 16, 2014