NCT02425696

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 19, 2018

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

April 21, 2015

Last Update Submit

January 17, 2018

Conditions

Keywords

right-to-left shuntcontrast-enhanced transcranial Dopplermigrainesilent cerebral infarction

Outcome Measures

Primary Outcomes (1)

  • contrast-enhanced transcranial Doppler

    1 year

Secondary Outcomes (1)

  • brain MRI

    1 year

Study Arms (2)

group 1

Normal individuals without migraine

group 2

Migraineurs

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Migraine DisordersCerebral Infarction

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain InfarctionBrain IschemiaCerebrovascular DisordersStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yingqi Xing, MD, PhD

    The First Hospital of Jilin University

    STUDY CHAIR
  • Yi Yang, MD, PhD

    The First Hospital of Jilin University

    STUDY DIRECTOR
  • Yuzhu Guo

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR
  • Jie Zhang, MD

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR
  • Sibo Wang

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Head and Neck Vascular Ultrasound Center

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

January 19, 2018

Record last verified: 2016-10

Locations