Norwegian Microemboli in Acute Stroke Study (NOR-MASS)

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke; Embolic Stroke; Microemboli

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Sander Aarli, MD; Phone Number: +4799557918; Email: drar@helse-bergen.no
• Study Contact Backup: Name: Annette Fromm, MD, PhD; Email: atfm@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Sander Aarli, MD; Phone Number: +4799557918; Email: drar@helse-bergen.no
    • Contact: Annette Fromm, MD, PhD; Email: atfm@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of circulating microemboli	Up to 24 hours after symptom onset

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Embolic Stroke
• Other Study ID Numbers: REK 2018/589

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No