Clinical trial NCT03543319: Norwegian Microemboli in Acute Stroke Study
Official title: Norwegian Microemboli in Acute Stroke Study (NOR-MASS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Embolic Stroke
Microemboli
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2018-06-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Prevalence of circulating microemboli
timeFrame: Up to 24 hours after symptom onset
Secondary outcomes:
measure: Prevalence of circulating microemboli as a function of time and antithrombotic drugs
timeFrame: 3 days after symptom onset
measure: Prevalence of MRI DWI lesions
timeFrame: 18-36 hours after symptom onset
measure: Recurrence of ischemic stroke/TIA
timeFrame: 3 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References: