Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
Ključne riječi
Sažetak
Opis
This study is a multicenter, prospective, population-based cohort study with consecutive inclusion of patients in which the diagnosis of IIH is suspected. This study is carried out in collaboration between the Danish Headache Center, Rigshospitalet-Glostrup, and the Neurological Department at Odense University Hospital.
Patients are eligible for inclusion into the study if:
1. IIH is suspected
2. > 18 years old and able to provide written informed consent.
At baseline included patients will have:
A.) Medical history B.) Neurological, ophthalmological and general medical examination C.) Relevant neuro-imaging D.) Blood samples and lumbar puncture F.) Evaluation by other specialist, including neuro-psychologists, if appropriate.
Subsequently patients are divided into three sub-groups according to revised Friedmann criteria:
1. Certain IIH or IIH-WOP
2. Suspected, but unconfirmed, IIH
3. IIH ruled out
Patients are followed at a headache center and by neuro-ophthalmologist according to standard clinical practice.
Datumi
| Posljednja provjera: | 06/30/2019 |
| Prvo podneseno: | 07/11/2019 |
| Predviđena prijava predata: | 07/22/2019 |
| Prvo objavljeno: | 07/24/2019 |
| Zadnje ažuriranje poslato: | 07/22/2019 |
| Posljednje ažuriranje objavljeno: | 07/24/2019 |
| Stvarni datum početka studija: | 02/13/2018 |
| Procijenjeni datum primarnog završetka: | 05/30/2022 |
| Predviđeni datum završetka studije: | 05/30/2022 |
Stanje ili bolest
Intervencija / liječenje
Other: Standard treatment
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Certain IIH or IIH-WOP According to revised diagnostic criteria, Friedmann, 2013. | |
| Suspected IIH IIH is suspected, does not fulfill diagnostic criteria. | |
| IIH ruled out Patients in whom another diagnosis is made. |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 18 Years To 18 Years |
| Polovi podobni za studiranje | All |
| Metoda uzorkovanja | Non-Probability Sample |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | Inclusion Criteria: 1. Able to and willing to provide informed consent 2. More than 18 years of age 3. Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist) Exclusion Criteria: 1.) Unable to consent (e.g. language, mental retardation). |
Ishod
Primarne mjere ishoda
1. Biomarkers of IIH (diagnostic and prognostic) [2 years]
2. Visual status at conclusion of study [2 years]
3. Visual status at conclusion of study [2 years]
4. Visual status at conclusion of study [2 years]
5. Headache status at conclusion of study [2 years]
6. Biomarkers of IIH (diagnostic and prognostic) [2 years]
Sekundarne mjere ishoda
1. Baseline characteristics related to poor outcome [1 year]
2. Results of neuropsychological evaluations [1 year]
3. Treatment and follow-up [3 years]
4. Baseline characteristics related to IIH diagnosis [2 years]
5. Weight change in a standard care program [2 years]
6. Diagnostic criteria and their use in the clinical setting [2 years]
7. Clinical markers related to disease activity [2 years]
8. Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline [2 years]
