Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
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.
তারিখ
| সর্বশেষ যাচাই করা হয়েছে: | 06/30/2019 |
| প্রথম জমা দেওয়া: | 07/11/2019 |
| আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 07/22/2019 |
| প্রথম পোস্ট: | 07/24/2019 |
| সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 07/22/2019 |
| সর্বশেষ আপডেট পোস্ট: | 07/24/2019 |
| আসল অধ্যয়ন শুরুর তারিখ: | 02/13/2018 |
| আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 05/30/2022 |
| আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 05/30/2022 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Other: Standard treatment
পর্যায়
বাহু গ্রুপ
| বাহু | হস্তক্ষেপ / চিকিত্সা |
|---|---|
| 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. |
যোগ্যতার মানদণ্ড
| বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
| লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
| নমুনা পদ্ধতি | Non-Probability Sample |
| স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
| নির্ণায়ক | 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). |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
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]
মাধ্যমিক ফলাফলের ব্যবস্থা
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]
