Ischemic StrokeNOR-MASSNCT03543319
Norwegian Microemboli in Acute Stroke Study
An observational study of Ischemic Stroke and Embolic Stroke, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Embolic Stroke, Microemboli
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- 12 Jun 2018to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with acute ischemic stroke or TIA admitted to Haukeland University Hospital. All stroke sub-types, severities and vascular distributions are eligible.
Who may be able to join
- Admitted to hospital < 24 hours after onset of ischemic stroke
Who cannot join
- Temporal bone window inadequate for transcranial Doppler examination
- Participation in ongoing sonothrombolysis study (NOR-SASS 2)
- Reduced ability to cooperate
- No informed consent can be obtained
Trial locations and contacts
1 site in 1 country.
Annette Fromm, MD, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Sander Aarli, MD, +4799557918, drar@helse-bergen.no
Annette Fromm, MD, PhD, atfm@helse-bergen.no
About this study
Official title: Norwegian Microemboli in Acute Stroke Study (NOR-MASS)
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.
- Conditions
- Ischemic Stroke, Embolic Stroke, Microemboli
- Medical subject headings
- Ischemic Stroke, Embolic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of circulating microemboli
Measured: Up to 24 hours after symptom onset
Secondary outcomes (3)
Prevalence of circulating microemboli as a function of time and antithrombotic drugs
Measured: 3 days after symptom onset
Prevalence of MRI DWI lesions
Measured: 18-36 hours after symptom onset
Recurrence of ischemic stroke/TIA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start12 Jun 2018
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543319
- Sponsor's protocol ID
- REK 2018/589
- Acronym
- NOR-MASS
- Status last verified
- Jun 2018
- First submitted
- 11 May 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aarli SJ, Thomassen L, Logallo N, Kvistad CE, Naess H, Fromm A. Prolonged and repeated microemboli detection in acute ischemic stroke - The Norwegian Microemboli in Acute Stroke Study (NOR-MASS). J Stroke Cerebrovasc Dis. 2024 Sep;33(9):107849. doi: 10.1016/j.jstrokecerebrovasdis.2024.107849. Epub 2024 Jul 5.
PubMed 38972617
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Microemboli in Acute Stroke Study (NOR-MASS)
- ClinicalTrials.gov ID
- NCT03543319
- Acronym / sponsor ID
- NOR-MASS / REK 2018/589
- Conditions
- Ischemic Stroke, Embolic Stroke, Microemboli
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke or TIA admitted to Haukeland University Hospital. All stroke sub-types, severities and vascular distributions are eligible.
Key inclusion criteria (1 listed)
- Admitted to hospital < 24 hours after onset of ischemic stroke
Key exclusion criteria (4 listed)
- Temporal bone window inadequate for transcranial Doppler examination
- Participation in ongoing sonothrombolysis study (NOR-SASS 2)
- Reduced ability to cooperate
- No informed consent can be obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of circulating microemboli
Time frame: Up to 24 hours after symptom onset
3 secondary outcomes
Prevalence of circulating microemboli as a function of time and antithrombotic drugs
Time frame: 3 days after symptom onset
Prevalence of MRI DWI lesions
Time frame: 18-36 hours after symptom onset
Recurrence of ischemic stroke/TIA
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 38972617Aarli SJ, Thomassen L, Logallo N, Kvistad CE, Naess H, Fromm A. Prolonged and repeated microemboli detection in acute ischemic stroke - The Norwegian Microemboli in Acute Stroke Study (NOR-MASS). J Stroke Cerebrovasc Dis. 2024 Sep;33(9):107849. doi: 10.1016/j.jstrokecerebrovasdis.2024.107849. Epub 2024 Jul 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Fromm, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Embolic Stroke, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sander Aarli, MD (+4799557918, drar@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of circulating microemboli (time frame: Up to 24 hours after symptom onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.