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NCT02425696 Clinical Trial

Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population

Migraine Clinical Trial

Official title:
Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02425696
Other study ID # RLS-1dzx
Secondary ID
Status Completed
Phase N/A
First received April 21, 2015
Last updated January 17, 2018
Start date June 2015
Est. completion date August 2017

Study information
Verified date October 2016
Source First Hospital of Jilin University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1100
Est. completion date August 2017
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China First Hospital of Jilin University Changchun Jilin

Sponsors (1)
Lead Sponsor Collaborator
Yingqi Xing

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary contrast-enhanced transcranial Doppler 1 year
Secondary brain MRI 1 year
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