ClinicalTrials.gg
Status unknownNCT03543319NOR-MASSUpdated Feb 22, 2019

Norwegian Microemboli in Acute Stroke Study

An observational study in Ischemic Stroke, Embolic Stroke and Microemboli, sponsored by Haukeland University Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.

Primary conditionEmbolic StrokeRegistry: Ischemic StrokeReclassifiedWhy we changed it
Registry
Ischemic Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Embolic Stroke
Why
  1. The study's listed conditions name Embolic Stroke, a narrower term within Ischemic Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Haukeland University Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

BACKGROUND: The cause of ischemic stroke remains undetermined in 30-40% of the cases, but circulating blood clots (thromboemboli) are a postulated common denominator in approx. 75% of patients. Transcranial Doppler monitoring (TCDM) is a non-invasive method of detecting circulating microemboli (CME) in the human cerebral circulation. The method is not used systematically in unselected groups of patients with repeated long-term registrations. New ultrasound equipment is ambulatory, less unpleasant for the patient and allows extended monitoring sessions. This may vastly simplify the implementation of TCDM as a clinically useful diagnostic tool.

AIMS: Determine the usefulness of TCDM in acute stroke diagnostics by assessing prevalence and frequency of CME in unselected patients with ischemic stroke, the influence of antithrombotic drugs on CME and the relationship between MES and recurrent stroke or transient ischemic attack (TIA).

HYPOTHESES: Prevalence and frequency of CME are higher during the first 24 hours than at later follow-up. Stroke etiology can be assessed by the presence or absence of CME. Presence of CME is associated with increased risk of recurrent TIA of stroke within 3 months and 1 year. Cessation of CME after the start of antithrombotic treatment is associated with reduced risk of recurrent TIA or stroke.

Read the detailed description
  • Standardized questionnaire
  • Clinical work-up in accordance with hospital standard operating procedures, i.e. radiological and cardiological procedures, neurovascular ultrasound, clinical scoring, etc.
  • 1st Transcranial Doppler monitoring (TCDM) at admission if within 24 hours after stroke onset (day 1). TCDM is repeated at 18-36 hours and at day 3. Microembolic signals are automatically registered by the software and subsequently verified manually.
02

Conditions studied

  • Ischemic Stroke
  • Embolic Stroke
  • Microemboli

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03

In context

Embolic Stroke Reclassified

40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.

This study's planned enrollment of 400 is close to the median of 364 across 27 observational studies indexed under Embolic Stroke.

Browse Embolic Stroke studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Compared within Embolic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ischemic Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with acute ischemic stroke or TIA admitted to Haukeland University Hospital. All stroke sub-types, severities and vascular distributions are eligible.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Admitted to hospital \< 24 hours after onset of ischemic stroke

Exclusion criteria

Exclusion Criteria:

  • Temporal bone window inadequate for transcranial Doppler examination
  • Participation in ongoing sonothrombolysis study (NOR-SASS 2)
  • Reduced ability to cooperate
  • No can be obtained
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of circulating microemboli

    Time frame: Up to 24 hours after symptom onset

Secondary outcomes

  1. Prevalence of circulating microemboli as a function of time and antithrombotic drugs

    Time frame: 3 days after symptom onset

  2. Prevalence of MRI DWI lesions

    Time frame: 18-36 hours after symptom onset

  3. Recurrence of ischemic stroke/TIA

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2018 (actual). Primary completion is estimated for Jun 2020, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2018
First posted
Jun 1, 2018
StartActual
Jun 12, 2018
Primary completionEst.
Jun 2020
CompletionEst.
Dec 2020
Last update
Feb 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03543319
Responsible party
Sponsor
First posted
Jun 1, 2018
Start date
Jun 12, 2018
Primary completion
Jun 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Feb 22, 2019

Study contacts

Sander Aarli, MD
Contact
drar@helse-bergen.no
+4799557918
Annette Fromm, MD, PhD
Contact
atfm@helse-bergen.no

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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