Norwegian Microemboli in Acute Stroke Study

NCT ID: NCT03543319

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2020-12-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Sander Aarli, MD

Role: CONTACT

drar@helse-bergen.no

+4799557918

Annette Fromm, MD, PhD

Role: CONTACT

atfm@helse-bergen.no

Facility Contacts

Sander Aarli, MD

Role: primary

drar@helse-bergen.no

+4799557918

Annette Fromm, MD, PhD

Role: backup

atfm@helse-bergen.no

References

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.

Reference Type: DERIVED

PMID: 38972617 (View on PubMed)

Other Identifiers

REK 2018/589

Identifier Type: -

Identifier Source: org_study_id