Norwegian Microemboli in Acute Stroke Study (NOR-MASS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03543319|
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : February 22, 2019
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|
- 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|
|Official Title:||Norwegian Microemboli in Acute Stroke Study (NOR-MASS)|
|Actual Study Start Date :||June 12, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
- Prevalence of circulating microemboli [ Time Frame: Up to 24 hours after symptom onset ]
- Prevalence of circulating microemboli as a function of time and antithrombotic drugs [ Time Frame: 3 days after symptom onset ]
- Prevalence of MRI DWI lesions [ Time Frame: 18-36 hours after symptom onset ]
- Recurrence of ischemic stroke/TIA [ Time Frame: 3 months ]
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
|Contact: Sander Aarli, MDfirstname.lastname@example.org|
|Contact: Annette Fromm, MD, PhDemail@example.com|
|Haukeland University Hospital||Recruiting|
|Bergen, Norway, 5021|
|Contact: Sander Aarli, MD +4799557918 firstname.lastname@example.org|
|Contact: Annette Fromm, MD, PhD email@example.com|