Right-to-left ShuntNCT02425696
Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population
An observational study of Right-to-left Shunt and Migraine, run by Yingqi Xing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Right-to-left Shunt, Migraine, Cerebral Infarction
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Aug 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects with stenotic intracranial or extracranial arteries or intracranial abnormalities diagnosed with TCD.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Right-to-left Shunt, Migraine, Cerebral Infarction
- Keywords
- right-to-left shunt, contrast-enhanced transcranial Doppler, migraine, silent cerebral infarction
- Medical subject headings
- Migraine Disorders, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Normal individuals without migraine | |
| group 2 | Migraineurs |
What is being measured
The primary outcome is the main question the study is designed to answer.
contrast-enhanced transcranial Doppler
Measured: 1 year
Secondary outcomes (1)
brain MRI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Right-to-left ShuntStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yingqi Xing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yingqi Xing, The First Hospital of Jilin University
- Investigators
- Yingqi Xing, MD, PhD, Study chair, The First Hospital of Jilin UniversityYi Yang, MD, PhD, Study director, The First Hospital of Jilin UniversityYuzhu Guo, Principal investigator, The First Hospital of Jilin UniversityJie Zhang, MD, Principal investigator, The First Hospital of Jilin UniversitySibo Wang, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425696
- Sponsor's protocol ID
- RLS-1dzx
- Status last verified
- Oct 2016
- First submitted
- 21 Apr 2015
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jiang XH, Wang SB, Tian Q, Zhong C, Zhang GL, Li YJ, Lin P, You Y, Guo R, Cui YH, Xing YQ. Right-to-left shunt and subclinical ischemic brain lesions in Chinese migraineurs: a multicentre MRI study. BMC Neurol. 2018 Feb 14;18(1):18. doi: 10.1186/s12883-018-1022-7.
PubMed 29444659
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population
- ClinicalTrials.gov ID
- NCT02425696
- Acronym / sponsor ID
- RLS-1dzx
- Conditions
- Right-to-left Shunt, Migraine, Cerebral Infarction
- Keywords
- right-to-left shunt, contrast-enhanced transcranial Doppler, migraine, silent cerebral infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Yingqi XingUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –Normal individuals without migraine |
| group 2 | – | –Migraineurs |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects with stenotic intracranial or extracranial arteries or intracranial abnormalities diagnosed with TCD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
contrast-enhanced transcranial Doppler
Time frame: 1 year
1 secondary outcome
brain MRI
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Derived from this study: PubMed 29444659Jiang XH, Wang SB, Tian Q, Zhong C, Zhang GL, Li YJ, Lin P, You Y, Guo R, Cui YH, Xing YQ. Right-to-left shunt and subclinical ischemic brain lesions in Chinese migraineurs: a multicentre MRI study. BMC Neurol. 2018 Feb 14;18(1):18. doi: 10.1186/s12883-018-1022-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingqi Xing, MD, PhD study chair
The First Hospital of Jilin University
Yi Yang, MD, PhD study director
The First Hospital of Jilin University
Yuzhu Guo principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right-to-left Shunt and Migraine, run by Yingqi Xing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contrast-enhanced transcranial Doppler (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.