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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418766
Recruitment Status : Unknown
Verified March 2020 by The First Hospital of Jilin University.
Recruitment status was:  Recruiting
First Posted : February 1, 2018
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
The First Hospital of Jilin University

Study Description
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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.

Condition or disease
White Matter Disease Right-to-left Shunt Migraine Disorders

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 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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Chinese Patients With Migraine:a Multicenter Study. CAMBRAIN Study.
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Groups and Cohorts
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Group/Cohort
Normal
Normal healthy individual without migraine.
Magraine
Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders.


Outcome Measures
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Primary Outcome Measures :
  1. contrast-enhanced transcranial Doppler (c-TCD) [ Time Frame: 1 year ]
    Brain MRI


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418766


Contacts
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Contact: Yingqi Xing, MD,PhD 15844047846 xingyq2009@sina.com
Contact: Sibo Wang, MD,PhD 15844008297 wangsibo92@163.com

Locations
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China, Jilin
First hospital of Jilin Uni Recruiting
Changchun, Jilin, China, 130000
Contact: Yingqi Xing, PhD         
Principal Investigator: Yishui Zhang, MD         
Sponsors and Collaborators
The First Hospital of Jilin University
National Natural Science Foundation of China
Investigators
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Study Chair: Yingqi Xing, MD,PhD The First Hospital of Jilin University
Principal Investigator: Sibo Wang, MD,PhD The First Hospital of Jilin University
Study Director: Yi Yang, MD,PhD The First Hospital of Jilin University
Principal Investigator: Yongsheng Gao, MD The First Hospital of Jilin University
More Information
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Additional Information:

Publications of Results:

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Responsible Party: The First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03418766    
Other Study ID Numbers: CAMBRAIN
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Hospital of Jilin University:
Right-to-left Shunt
Brain White Matter Lesions
Migraine
Additional relevant MeSH terms:
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Migraine Disorders
Leukoencephalopathies
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases