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Norwegian Microemboli in Acute Stroke Study (NOR-MASS)

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ClinicalTrials.gov Identifier: NCT03543319
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

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.


Condition or disease
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
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Norwegian Microemboli in Acute Stroke Study (NOR-MASS)
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Prevalence of circulating microemboli [ Time Frame: Up to 24 hours after symptom onset ]

Secondary Outcome Measures :
  1. Prevalence of circulating microemboli as a function of time and antithrombotic drugs [ Time Frame: 3 days after symptom onset ]
  2. Prevalence of MRI DWI lesions [ Time Frame: 18-36 hours after symptom onset ]
  3. Recurrence of ischemic stroke/TIA [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543319


Contacts
Contact: Sander Aarli, MD +4799557918 drar@helse-bergen.no
Contact: Annette Fromm, MD, PhD atfm@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Sander Aarli, MD    +4799557918    drar@helse-bergen.no   
Contact: Annette Fromm, MD, PhD       atfm@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03543319     History of Changes
Other Study ID Numbers: REK 2018/589
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases