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

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ClinicalTrials.gov Identifier: NCT03418766
Recruitment Status : Not yet recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
First Hospital of Jilin University

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 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.
Anticipated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

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.



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



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.

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

Sponsors and Collaborators
First Hospital of Jilin University
Investigators
Study Chair: Yingqi Xing, MD,PhD First Hospital of Jilin University
Principal Investigator: Sibo Wang, MD,PhD First Hospital of Jilin University
Study Director: Yi Yang, MD,PhD First Hospital of Jilin University
Principal Investigator: Yongsheng Gao, MD First Hospital of Jilin University

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Hospital of Jilin University:
Right-to-left Shunt
Brain White Matter Lesions
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Leukoencephalopathies
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases