Providing diagnostic accuracy in acute onset, continuous dizziness.

Completed

• Conditions: cerebral infarction. Acute Vestibular Syndrome.; Stroke; 10022396; 10007963

• Registration Number: NL-OMON52153
• Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

- Acute onset, continuous dizziness, still present at arrival on the ED as the
principal reason for the ED visit.
- Presentation within 24 hours after onset of dizziness.
- Age 18 years or older.
- For substudy 1: Presentation at the ED of one of the following centers:
Haaglanden Medical Center, Haga Hospital, Jeroen Bosch Hospital or Gelre
Hospital.
- For substudy 1: Early MRI DWI <48 hours of symptom onset without explanatory
lesion.
- For substudy 2: Presentation at the ED of the Haga Hospital.
- For substudy 2: Vestibular neuritis as most probable diagnosis as determined
by the treating physician on the ED, based on i.a. horizontal-torsional
nystagmus in one direction and positive HIT.

Exclusion Criteria

- Clear signs of benign paroxysmal positional vertigo (BPPV) (i.e. acute onset,
continuous dizziness successfully treated by canalith repositioning).
- Recognizable recurrent vertigo or acute onset dizziness compatible with a
known previous diagnosis of Meniere*s disease or vestibular migraine;
- New deficits upon neurological examination (i.e. ataxia, dysarthria,
spontaneous skew deviation, gaze palsy or lowered state of consciousness (i.e.
Glasgow Coma Scale (GCS) score <14)). Nystagmus and gait imbalance are allowed.
- Known pregnancy at the time of inclusion.
- Known contra-indication for MRI (e.g. claustrophobia, non MRI-compatible
pacemaker or ICD).
- Clear medical condition other than a central or a peripheral vestibular
disorder that explains acute onset, continuous dizziness. Examples are
hypotension, sepsis, medication related.
- Previous inclusion in this study.
- Unable to undergo follow up (e.g. life expectancy <3 months, severe cognitive
impairment, no permanent residence in the Netherlands).
- Unable to give informed consent (e.g. cognitive impairment, mental
retardation).
- Insufficient command of the Dutch language.
- For substudy 2 additional exclusion criterium: known allergy to gadolinium.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is final diagnosis by the expert panel after three months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are health care costs, sensitivity/specificity of early<br /><br>(<24-48 hours) and delayed (>72 hours and <10 days) MRI of the brain and of a<br /><br>biomarker.</p><br>