Clinical trial NCT02425696: Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population
Official title: Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Right-to-left Shunt
Migraine
Cerebral Infarction
Keywords: right-to-left shunt
contrast-enhanced transcranial Doppler
migraine
silent cerebral infarction
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 1100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: 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. Patients of group 2 with large RLS are required to take TTE and brain MRI.

Brief summary: The purpose of the study is to evaluate the prevalence and extent of right-to-left shunt (RLS) in Chinese migraineurs, and the morbidity of silent cerebral infarction in migraineurs.

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 c-TCD). For migraineurs with large RLS further examinations (c-TTE and brain MRI) are required. Up to 10 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, MIDAS and HIT-6 questionnaire.

Eligibility criteria: Inclusion Criteria:

* For group 1: Normal healthy individual without migraine.
* For group 2: Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders.

Exclusion Criteria:

* Subjects with stenotic intracranial or extracranial arteries or intracranial abnormalities diagnosed with TCD.

Primary outcomes:
measure: contrast-enhanced transcranial Doppler
timeFrame: 1 year
Secondary outcomes:
measure: brain MRI
timeFrame: 1 year
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
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: Yi Yang, MD, PhD
role: STUDY_DIRECTOR
affiliation: The First Hospital of Jilin University
name: Yuzhu Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Jie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Sibo Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang XH, Wang SB, Tian Q, Zhong C, Zhang GL, Li YJ, Lin P, You Y, Guo R, Cui YH, Xing YQ. Right-to-left shunt and subclinical ischemic brain lesions in Chinese migraineurs: a multicentre MRI study. BMC Neurol. 2018 Feb 14;18(1):18. doi: 10.1186/s12883-018-1022-7.