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Table 1 SONOBIRDIE trial: the schedule of enrollment, interventions and assessments

From: SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial – study protocol for a randomized controlled trial

 

Visit 1

Baseline and randomization

Visit 2

(maximum 24 h before CEA)

Allocation (during CEA)

Visit 3

(24–48 h after CEA)

Visit 4

(30 ± 2 days after CEA)

Visit 5

(365 ± 14 days after CEA)

Medical and surgical history

X

X

 

X

X

X

Demographics

X

     

Physical examination

X

X

 

X

X

X

Vital signs

X

X

   

X

Neurological examination

X

X

 

X

X

X

NIHSS

X

X

 

X

X

X

mRS

X

X

 

X

X

X

Duplex sonography

X

X

 

X

X

X

CTA, MRA or DSA

X

     

Signed informed consent

X

     

Eligibility criteria

X

     

MRI (for substudy only)

 

X

 

X (24 ± 4 h)

  

ACE-R

 

X

 

X

X

X

MMSE

 

X

 

X

X

X

Clock-drawing Test

 

X

 

X

X

X

Verbal Fluency Test

 

X

 

X

X

X

Sonolysis

  

X

   

Sham procedure

  

X

   

Adverse event, SAE

   

X

X

X

Endpoints

   

X

X

X

  1. ACE-R Addenbrooke’s Cognitive Examination Revised, CEA carotid endarterectomy, CTA computed tomography angiography, DSA digital subtraction angiography, MMSE Mini Mental State Examination, MRA magnetic resonance angiography, MRI magnetic resonance imaging, mRS modified Rankin score, NIHSS National Institutes of Health Stroke Scale, SAE serious adverse event