Ischemic Stroke Clinical Trial
— NOR-MASSOfficial title:
Norwegian Microemboli in Acute Stroke Study (NOR-MASS)
NCT number | NCT03543319 |
Other study ID # | REK 2018/589 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 12, 2018 |
Est. completion date | December 2020 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | University of Bergen |
Norway,
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 |
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