Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population

NCT ID: NCT02425696

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Right-to-left Shunt Migraine Cerebral Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1

Normal individuals without migraine

No interventions assigned to this group

group 2

Migraineurs

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yingqi Xing

OTHER

Sponsor Role lead

Responsible Party

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Yingqi Xing

Director of Head and Neck Vascular Ultrasound Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yingqi Xing, MD, PhD

Role: STUDY_CHAIR

The First Hospital of Jilin University

Yi Yang, MD, PhD

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Yuzhu Guo

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Jie Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Sibo Wang

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

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First Hospital of Jilin University

Changchun, Jilin, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 29444659 (View on PubMed)

Other Identifiers

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RLS-1dzx

Identifier Type: -

Identifier Source: org_study_id

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