Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

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StatusMerekrut

Sponsor

Danish Headache Center

Kolaborator

Odense University Hospital

UJI KLINIS: NCT04032379

BioSeek: nct04032379

Kata kunci

hipertensi intrakranial idiopatik

Abstrak

Idiopathic intracranial hypertension (IIH) is a condition of unknown etiology, primarily affecting overweight females of childbearing age. Typically, patients experience headache and visual symptoms due to increased intracranial pressure (ICP) and papilledema. The diagnosis is difficult, and outcomes vary from no sequelae to blindness or chronic headaches. No clear prognostic indicators exist. Treatment consists of medication, weight loss, and possibly surgical intervention.There is an unmet need of defining biomarkers with prognostic or diagnostic value and defining predictors of a poor outcome.

This project is a prospective, population-based cohort study including clinical data and a biobank (blood samples and cerebrospinal fluid).

The investigator's primary aim is to identify biomarkers of diagnostic or prognostic value and to create a clinical IIH database. The clinical database will answer questions about patient characteristics at baseline and during follow-up, identify predictors of outcome, and help create a standardized programme for follow-up and

Deskripsi

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.

tanggal

Terakhir Diverifikasi:	06/30/2019
Pertama Dikirim:	07/11/2019
Perkiraan Pendaftaran Telah Dikirim:	07/22/2019
Pertama Diposting:	07/24/2019
Pembaruan Terakhir Dikirim:	07/22/2019
Pembaruan Terakhir Diposting:	07/24/2019
Tanggal Mulai Studi Sebenarnya:	02/13/2018
Perkiraan Tanggal Penyelesaian Utama:	05/30/2022
Perkiraan Tanggal Penyelesaian Studi:	05/30/2022

Kondisi atau penyakit

Benign Intracranial Hypertension

Intervensi / pengobatan

Other: Standard treatment

Tahap

Kelompok Lengan

Lengan	Intervensi / pengobatan
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.

Kriteria kelayakan

Usia yang Layak untuk Belajar	18 Years Untuk 18 Years
Jenis Kelamin yang Layak untuk Belajar	All
Metode pengambilan sampel	Non-Probability Sample
Menerima Relawan Sehat	Iya
Kriteria	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).

Hasil

Ukuran Hasil Utama

1. Biomarkers of IIH (diagnostic and prognostic) [2 years]

Analyses of CSF and blood for protein-markers (method: Proteomics)

2. Visual status at conclusion of study [2 years]

Assessment of visual fields

3. Visual status at conclusion of study [2 years]

Assessment of OCT

4. Visual status at conclusion of study [2 years]

Assessment of visual acuity

5. Headache status at conclusion of study [2 years]

Prevalence of chronic headache (>=15 headache days per month)

6. Biomarkers of IIH (diagnostic and prognostic) [2 years]

Analyses of CSF and blood for markers of metabolism (method: Metabolomics)

Ukuran Hasil Sekunder

1. Baseline characteristics related to poor outcome [1 year]

Poor outcome is defined as either a.) Persistent visual field defects, decreased visual acuity after 12 months and or b.) Headache >= 15 days per month after 12 months

2. Results of neuropsychological evaluations [1 year]

Standard neuro-psychological tests

3. Treatment and follow-up [3 years]

Length and type of treatment and follow-up

4. Baseline characteristics related to IIH diagnosis [2 years]

Evaluation of disease presentation in the different sub-groups focusing on headache phenotype, visual disturbances and pulsatile tinnitus.

5. Weight change in a standard care program [2 years]

Unit of measurement is BMI

6. Diagnostic criteria and their use in the clinical setting [2 years]

Revised Friedmann criteria of 2013

7. Clinical markers related to disease activity [2 years]

Clinical markers of relevance: Headache phenotype, pulsatile tinnitus, visual disturbances, weight changes.

8. Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline [2 years]

ICP is measured by lumbar puncture, borderline elevated ICP is considered >20-30 mmH2O