Norwegian Microemboli in Acute Stroke Study

NCT03543319 | Unknown

• 1 other identifier: REK 2018/589
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Embolic Stroke; Microemboli

Outcome Measures

Primary Outcomes (1)

• Prevalence of circulating microemboli

  Up to 24 hours after symptom onset

Secondary Outcomes (3)

• Prevalence of circulating microemboli as a function of time and antithrombotic drugs

  3 days after symptom onset

• Prevalence of MRI DWI lesions

  18-36 hours after symptom onset

• Recurrence of ischemic stroke/TIA

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 38972617 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Embolic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sander Aarli, MD

CONTACT

+4799557918; drar@helse-bergen.no

Annette Fromm, MD, PhD

CONTACT

atfm@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 1, 2018
• Study Start: June 12, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 22, 2019

Record last verified: 2018-06

Locations

NO (1)