Evidence map›Paper›PMID 27980128›Full record

Trial reportStroke2017

NOR-SASS (Norwegian Sonothrombolysis in Acute Stroke Study): Randomized Controlled Contrast-Enhanced Sonothrombolysis in an Unselected Acute Ischemic Stroke Population.

Aliona Nacu, Christopher E Kvistad, Halvor Naess, Halvor Øygarden, Nicola Logallo, Jörg Assmus, Ulrike Waje-Andreassen, Kathinka D Kurz, Gesche Neckelmann, Lars Thomassen

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Stroke, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01949961 (Randomised Trial of Contrast-enhanced Sonothrombolysis in Acute Ischaemic Stroke), which is not on this map. Cited by 20 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01949961 naterminatednot on this map

Randomised Trial of Contrast-enhanced Sonothrombolysis in Acute Ischaemic Stroke

TypeinterventionalSponsorHaukeland University HospitalRan2016 to 2019Enrolled59ConditionsIschemic StrokeArmsUltrasound, Sham ultrasound
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Pooled it
  7. Overview of Therapeutic Ultrasound Applications and Safety Considerations: 2024 Update.Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine · 2025
    Review
  8. Observational
  9. Sonothrombolysis for Ischemic Stroke.Journal of cardiovascular development and disease · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Aliona NacuFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway. aliona.nacu@uib.no.
Christopher E KvistadFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.
Halvor NaessFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.
Halvor ØygardenFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.
Nicola LogalloFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.
Jörg AssmusFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.
Ulrike Waje-AndreassenFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.
Kathinka D KurzFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.
Gesche NeckelmannFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.
Lars ThomassenFrom the Department of Neurology (A.N., C.E.K., H.N., H.Ø., N.L., U.W.-A., L.T.) and Department of Radiology (G.N.), Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (A.N., H.N., H.Ø., L.T.) and Department of Biostatistics (J.A.), University of Bergen, Norway; and Center for Age-Related Medicine (H.N.) and Department of Radiology (K.D.K.), Stavanger University Hospital, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeThe NOR-SASS (Norwegian Sonothrombolysis in Acute Stroke Study) aimed to assess effect and safety of contrast-enhanced ultrasound treatment in an unselected acute ischemic stroke population.

methodsPatients treated with intravenous thrombolysis within 4.5 hours after symptom onset were randomized 1:1 to either contrast-enhanced sonothrombolysis (CEST) or sham CEST. A visible arterial occlusion on baseline computed tomography angiography was not a prerequisite for inclusion. Pulse-wave 2 MHz ultrasound was given for 1 hour and contrast (SonoVue) as an infusion for ≈30 minutes. Magnetic resonance imaging and angiography were performed after 24 to 36 hours. Primary study end points were neurological improvement at 24 hours defined as National Institutes of Health Stroke Scale score 0 or reduction of ≥4 National Institutes of Health Stroke Scale points compared with baseline National Institutes of Health Stroke Scale and favorable functional outcome at 90 days defined as modified Rankin scale score 0 to 1.

resultsA total of 183 patients were randomly assigned to either CEST (93 patient) or sham CEST (90 patients). The rates of symptomatic intracerebral hemorrhage, asymptomatic intracerebral hemorrhage, or mortality were not increased in the CEST group. Neurological improvement at 24 hours and functional outcome at 90 days was similar in the 2 groups both in the intention-to-treat analysis and in the per-protocol analysis.

conclusionsCEST is safe among unselected ischemic stroke patients with or without a visible occlusion on computed tomography angiography and with varying grades of clinical severity. There was, however, statistically no significant clinical effect of sonothrombolysis in this prematurely stopped trial. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01949961.

Indexed as

Population SurveillanceAgedAged, 80 and overBrain IschemiaFemaleHumansMaleMiddle AgedNorwayPhospholipidsProspective StudiesSingle-Blind MethodStrokeSulfur HexafluorideThrombolytic TherapyTissue Plasminogen Activatorcontrast agent BR1PhospholipidsSulfur HexafluorideTissue Plasminogen Activatorangiographybrainrandomized controlled trialsafetystroke

Identifiers

PMID27980128
PMCPMC5266415

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.