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

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ClinicalTrials.gov Identifier: NCT02425696
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Yingqi Xing, First Hospital of Jilin University

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.

Condition or disease
Right-to-left Shunt Migraine Cerebral Infarction

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 : Observational [Patient Registry]
Actual Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population
Actual Study Start Date : June 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2017

Group/Cohort
group 1
Normal individuals without migraine
group 2
Migraineurs



Primary Outcome Measures :
  1. contrast-enhanced transcranial Doppler [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. brain MRI [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   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. Patients of group 2 with large RLS are required to take TTE and brain MRI.
Criteria

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.

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): NCT02425696


Locations
China, Jilin
First Hospital of Jilin University
Changchun, Jilin, China, 130000
Sponsors and Collaborators
Yingqi Xing
Investigators
Study Chair: Yingqi Xing, MD, PhD First Hospital of Jilin University
Study Director: Yi Yang, MD, PhD First Hospital of Jilin University
Principal Investigator: Yuzhu Guo First Hospital of Jilin University
Principal Investigator: Jie Zhang, MD First Hospital of Jilin University
Principal Investigator: Sibo Wang First Hospital of Jilin University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yingqi Xing, Director of Head and Neck Vascular Ultrasound Center, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT02425696     History of Changes
Other Study ID Numbers: RLS-1dzx
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yingqi Xing, First Hospital of Jilin University:
right-to-left shunt
contrast-enhanced transcranial Doppler
migraine
silent cerebral infarction

Additional relevant MeSH terms:
Infarction
Migraine Disorders
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Stroke
Vascular Diseases
Cardiovascular Diseases