Clinical trial NCT03418766: The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Patients With Migraine
Official title: The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Chinese Patients With Migraine:a Multicenter Study. CAMBRAIN Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: White Matter Disease
Right-to-left Shunt
Migraine Disorders
Keywords: Right-to-left Shunt
Brain White Matter Lesions
Migraine
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2018-02-01
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We detect RLS through contrast-enhanced transcranial Doppler (c-TCD). The normal individuals will be selected to group 1, while those who suffer from migraine will be selected to group 2. All the participants are required to take c-TCD and brain MRI.

Brief summary: The purpose of the study is to evaluate the prevalence of white matter lesions in Chinese migraineurs with and without right-to-left shunt. The aim is to study the relationship among right-to-left shunt, migraine and white matter lesions.

Detailed description: This is a prospective multicenter study of Chinese population. Participants (normal individuals without migraine and migraineurs) are included after standardized diagnostic procedures (TCD and migraine diagnosis). For all the participants, brain MRI and c-TCD are required. Up to 10-15 study sites nationwide will be needed to recruit the planned participant population during a 1-year period.

The information of each participants will be registered, including basic facts, the longitudinal headache history, frequency, location, quality, intensity, duration, accompanied symptoms, precipitating and exacerbating factors, with or without aura, and Headache Impact Test-6 (HIT-6) questionnaire.

Eligibility criteria: Inclusion Criteria:

* patients who fulfilled the criteria for migraine according to the International Classification of Headache Disorders III-beta were included.

healthy volunteers without a history of migraine were included as controls.

Exclusion Criteria:

* Subjects were excluded from the study if they had severe arterial stenosis, an insufficient temporal window, inadequate cubital venous access, and/or were unable to perform the Valsalva manoeuvre (VM) because of severe heart or lung disease.

Primary outcomes:
measure: contrast-enhanced transcranial Doppler (c-TCD)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: First hospital of Jilin Uni
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yingqi Xing, MD,PhD
role: STUDY_CHAIR
affiliation: The First Hospital of Jilin University
name: Sibo Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Yi Yang, MD,PhD
role: STUDY_DIRECTOR
affiliation: The First Hospital of Jilin University
name: Yongsheng Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Del Sette M, Dinia L, Bonzano L, Roccatagliata L, Finocchi C, Parodi RC, Sivori G, Gandolfo C. White matter lesions in migraine and right-to-left shunt: a conventional and diffusion MRI study. Cephalalgia. 2008 Apr;28(4):376-82. doi: 10.1111/j.1468-2982.2008.01544.x. Epub 2008 Feb 22.