Norwegian Microemboli in Acute Stroke Study

Ischemic Stroke Clinical Trial

— NOR-MASS  

Official title:

Norwegian Microemboli in Acute Stroke Study (NOR-MASS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543319
• Other study ID #: REK 2018/589
• Status: Recruiting
• Start date: June 12, 2018
• Est. completion date: December 2020

Study information

• Verified date: June 2018
• Source: Haukeland University Hospital
• Contact: Sander Aarli, MD
• Phone: +4799557918
• Email: drar[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolic Stroke
• Ischemic Stroke
• Microemboli
• Stroke

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of circulating microemboli		Up to 24 hours after symptom onset
Secondary	Prevalence of circulating microemboli as a function of time and antithrombotic drugs		3 days after symptom onset
Secondary	Prevalence of MRI DWI lesions		18-36 hours after symptom onset
Secondary	Recurrence of ischemic stroke/TIA		3 months