The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Patients With Migraine

NCT ID: NCT03418766

Last Updated: 2020-07-23

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

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-15

Study Completion Date

2020-12-30

Brief Summary

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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

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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 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.

Conditions

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White Matter Disease Right-to-left Shunt Migraine Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

Normal healthy individual without migraine.

No interventions assigned to this group

Magraine

Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingqi Xing, MD,PhD

Role: STUDY_CHAIR

The First Hospital of Jilin University

Sibo Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Yi Yang, MD,PhD

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Yongsheng Gao, MD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

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First hospital of Jilin Uni

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingqi Xing, MD,PhD

Role: CONTACT

15844047846

Sibo Wang, MD,PhD

Role: CONTACT

15844008297

Facility Contacts

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Yingqi Xing, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 18294247 (View on PubMed)

Other Identifiers

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CAMBRAIN

Identifier Type: -

Identifier Source: org_study_id

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