- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02425696
Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population
Study Overview
Status
Conditions
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 c-TCD). For migraineurs with large RLS further examinations (c-TTE and brain MRI) are required. Up to 10 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, MIDAS and HIT-6 questionnaire.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jilin
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Changchun, Jilin, China, 130000
- First Hospital of Jilin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects with stenotic intracranial or extracranial arteries or intracranial abnormalities diagnosed with TCD.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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group 1
Normal individuals without migraine
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group 2
Migraineurs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
contrast-enhanced transcranial Doppler
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
brain MRI
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yuzhu Guo, The First Hospital of Jilin University
- Study Chair: Yingqi Xing, MD, PhD, The First Hospital of Jilin University
- Study Director: Yi Yang, MD, PhD, 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RLS-1dzx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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