NCT03418766

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 23, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

January 16, 2018

Last Update Submit

July 21, 2020

Conditions

Keywords

Right-to-left ShuntBrain White Matter LesionsMigraine

Outcome Measures

Primary Outcomes (1)

  • contrast-enhanced transcranial Doppler (c-TCD)

    Brain MRI

    1 year

Study Arms (2)

Normal

Normal healthy individual without migraine.

Magraine

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First hospital of Jilin Uni

Changchun, Jilin, 130000, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

LeukoencephalopathiesMigraine Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, PrimaryHeadache Disorders

Study Officials

  • Yingqi Xing, MD,PhD

    The First Hospital of Jilin University

    STUDY CHAIR
  • Sibo Wang, MD,PhD

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR
  • Yi Yang, MD,PhD

    The First Hospital of Jilin University

    STUDY DIRECTOR
  • Yongsheng Gao, MD

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingqi Xing, MD,PhD

CONTACT

Sibo Wang, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

February 1, 2018

Study Start

June 15, 2018

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

July 23, 2020

Record last verified: 2020-03

Locations