We hypothesize that the HINTS+ test is more reliable than early MRI imaging in patients with acute onset continuous dizziness. As a result it is hypothesized that HINTS+ clinical examination leads to lower costs and an improvement in Quality of Life.
ID
Bron
Verkorte titel
Aandoening
Acute vestibular syndrome. Vertebrobasilar/cerebellar stroke. Peripheral vestibular syndrome.
Ondersteuning
Co-financing St. Jacobusstichting.
In-kind contribution Neurobit Technologies.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Final diagnosis (stroke or peripheral) 3 months after inclusion.
Achtergrond van het onderzoek
This study is a prospective, multicenter, cohort investigation to determine the optimal diagnostic work-up for patients with isolated, acute onset, continuous dizziness presenting to emergency departments. Patients 18 years and older presenting to the ED with acute onset, continuous dizziness and without neurological deficits or clear other diagnosis will be included in this study. All patients will undergo HINTS+ test, standarized questionnaires and MRI brain within 24 hours A selected group of patients will undergo a MRI brain after 72 hours as well. Follow-up time is 3 months, with the primary study parameter being ‘final’ diagnosis after 3 months. We will determine the sensitivity, specificity, positive predictive and negative predictive value of both the HINTS+ test as MRI brain within 24 and after 72 hours. Furthermore we will perform an economic evaluation of the HINTS+ test using a budget impact analysis and cost utility analysis. Eventually study data will be used to draft a national guideline and decision model for the diagnostics and treatment of isolated, acute onset, continuous dizziness.
Doel van het onderzoek
We hypothesize that the HINTS+ test is more reliable than early MRI imaging in patients with acute onset continuous dizziness.
As a result it is hypothesized that HINTS+ clinical examination leads to lower costs and an improvement in Quality of Life.
Onderzoeksopzet
Day 0, Day 1, Day 3, Discharge, Follow-up after 3 months.
Onderzoeksproduct en/of interventie
Not applicable.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Acute onset, continuous dizziness, still present at arrival on the ED;
- Presentation within 24 hours after onset of dizziness;
- Age 18 years or older.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Clear signs of benign paroxysmal positional vertigo (BPPV) (i.e. acute onset, continuous dizziness successfully treated by canalith repositioning);
- A history of recognizable recurrent vertigo or acute onset, continuous dizziness compatible with Meniere’s disease or vestibular migraine;
- Deficits upon neurological examination other than a nystagmus (i.e. ataxia (gait imbalance is allowed), dysarthria, spontaneous skew deviation, gaze palsy or lowered state of consciousness (i.e. EMV <14));
- Pregnancy at the time of inclusion;
- Known contra-indication for MRI (e.g. claustrofobia, non MRI-compatible pacemaker or ICD);
- Clear medical condition other than stroke (central) or non-stroke (peripheral) vestibular disorder that explains acute onset, continuous dizziness. Examples are hypotension, sepsis, medication related;
- Previous inclusion in study;
- No informed consent;
- Unable to undergo follow up (e.g. life expectancy <3 months, severe cognitive impairment, no permanent residence in the Netherlands);
- Insufficient command of the Dutch language.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9197 |
| Ander register | METC LDD (Leiden Den Haag Delft) : P21.029 METC LDD |