Completed

Sonothrombolysis Potentiated by Microbubbles as a Novel Treatment of Acute Ischemic Stroke: a Prospective Randomized Pilot Study

What is being tested

Sulfur hexafluoride + ultrasounds

+ Recombinant tissue plasminogen activator

OtherDrug

Who is being recruted

Brain Diseases+4

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 18 Years

+30 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: August 2012

See protocol details

Summary

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

Last updated: August 10, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01678495

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

Last updated: August 10, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

7 inclusion criteria required to participate

A documented occlusion of the middle cerebral artery (MCA) documented by TCD and/or angioCT

Age > or = 18 years

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

No significant improvement before treatment

Show More Criteria

23 exclusion criteria prevent from participating

Acute pancreatitis; documented ulcerative gastrointestinal disease during the last 3 months, esophageal varices

Another stroke, a serious head injury or major surgery within the previous 3 month

Arterial aneurysm, arterial/venous malformations

Bacterial endocarditis, pericarditis

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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 II

Active Comparator

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital de la Santa Creu i Sant Pau

Barcelona, SpainOpen Hospital de la Santa Creu i Sant Pau in Google Maps

CompletedOne Study Center