StrokeNCT02397655
Vascular Ultrasound Screening in Patients With Ischemic Cerebrovascular Disease: a Multi-center Registry Study
An observational study of Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The purpose of this multicenter study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations with transient ischemic attack and ischemic stroke and analyze the influencing factors of atherosclerosis distribution pattern. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke
- How many people
- 12,012 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to May 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In hospital patients with transient ischemic attack and ischemic stroke.
Who may be able to join
None listed.
Who cannot join
- cerebral hemorrhage;
- vessel stenosis or occlusion caused by trauma,dissection or Takayasu's arteritis；
- Stroke patients caused by patent foramen ovale.
- Moyamoya disease;
- Multiple sclerosis;
- Mitochondrial myopathy.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Screening Carotid Artery and Intracranial Arteries by Ultrasound in Chinese Population With Transient Ischemic Attack and Ischemic Stroke: a Multi-center Registry Study
The purpose of this multicenter study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations with transient ischemic attack and ischemic stroke and analyze the influencing factors of atherosclerosis distribution pattern.
Read the detailed description
In this multicenter study, carotid artery color doppler flow imaging and transcranial color code doppler or transcranial doppler will be used to screen the extra-/intra-cranial vessels in chinese populations with transient ischemic attack and ischemic stroke. The aim of this study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations and analyze the influencing factors of atherosclerosis distribution pattern.
- Ultrasound examinations procedures: According to the guidelines of vascular ultrasonography published by the Chinese Medical Doctor Association (CMDA) in 2009. The stenosis degrees of carotid artery, vertebral artery, subclavian artery as well as the middle cerebral artery are evaluated followed the criteria we published previously (references 1-4).
- Radiology examinations procedures: Enrolled patients receive CT or MRI examinations to determine the presence and the location of cerebral infarction. If necessary, patients receive CT angiography (CTA) or MRI angiography (MRA) examinations to confirm the degrees of vessel stenosis.
- The data collected in this study including:
- The general informations of enrolled subjects, which include name, gender, age, resident address, telephone number.Each subject is assigned an unique identification number.
- The history of stroke risk factors, which include 1) hypertension; 2) atrial fibrillation; 3) smoking; 4) dyslipidemia; 5) diabetes mellitus; 6) lack of physical activity (the standard of physical activity is ≥ 3 times per week and ≥30 min per time and the duration time ≥ 1 year);7) obvious overweight or obesity (BMI ≥ 26.0 Kg/m2);8) with family history of stroke.
- The medicines used within recent 2 weeks, the surgery name (such as stenting, carotid endarterectomy)if any.
- The results of vascular ultrasonography, ultrasonic cardiogram, radiology examinations, laboratory tests results (blood glucose, lipoproteins pattern, homocystein, C reactive protein, fibrinogen)
- Statistic analysis plans The Statistical Package for Social Sciences (SPSS version 22.0) software was used for the statistical analyses.
- Numerical values are shown as the mean ± standard deviation (SD). The t test or One-way ANOVA is used to compare the numerical values among different groups.
- Chi square test is used to analyze the influencing factors on the intra-/extra-cranial atherosclerosis distribution patterns and the relationship between vessel stenosis degrees and the occurence of ischemic stroke.
- Logistic regression is used to analyze the influencing intensity of various risk factors on atherosclerosis and ischemic events.
- A P value <0.05 was considered statistically significant.
- Quality assurance plans:
- The medical centers implement the projects are the stroke prevention and treatment base hospitals awarded by National Health and Family Planning Commission, P.R. China. The medical centers have the instruments required in this study.
- Neurologists, neurosurgeons and vascular ultrasound physicians have received standard training hosted by National Health and Family Planning Commission stroke prevention engineering committee and obtained excellent records.
- All the centers conduct the project followed the uniform implementation plans and each center guarantee the data input in time and accurately.
- The project has the unique database and data input in uniform format.
- There are specific staffs to check the accuracy and completeness of data.
- Conditions
- Stroke
- Keywords
- stroke, ischemia, atherosclerosis, ultrasonography
- Medical subject headings
- Stroke, Ischemia, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography
By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, <50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion.
By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion.
Patients with one of the above arteries having >50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree.
Measured: 30 days after subjects recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Shanxi Medical University, Liaocheng Brains Hospital, Tianjin Huanhu Hospital, Baotou Central Hospital, The First Hospital of Jilin University, First Affiliated Hospital of Harbin Medical University, First Hospital of China Medical University, LanZhou University, First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Soochow University, Anhui Provincial Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, ZhuHai Hospital, Fujian Provincial Hospital, Mianyang Central Hospital, The Second Affiliated Hospital of Kunming Medical University, Brains Hospital of Hunan Province, Henan Provincial People's Hospital, Luoyang Central Hospital, National Health and Family Planning Commission Stroke Prevention Engineering Committee, Dalian Municipal Central Hospital
- Responsible party
- Sponsor
- Investigators
- Yang Hua, MD, Principal investigator, No.45, Changchun Road, Xicheng District, Beijing, China 100053
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397655
- Sponsor's protocol ID
- VUS-ICVD
- Status last verified
- Sep 2016
- First submitted
- 18 Mar 2015
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hua Y, Jia L, Li L, Ling C, Miao Z, Jiao L. Evaluation of severe subclavian artery stenosis by color Doppler flow imaging. Ultrasound Med Biol. 2011 Mar;37(3):358-63. doi: 10.1016/j.ultrasmedbio.2010.12.003. Epub 2011 Jan 26.
PubMed 21276651Hua Y, Meng XF, Jia LY, Ling C, Miao ZR, Ling F, Liu JB. Color Doppler imaging evaluation of proximal vertebral artery stenosis. AJR Am J Roentgenol. 2009 Nov;193(5):1434-8. doi: 10.2214/AJR.09.2624.
PubMed 19843764Hua Y, Liu BB, Ling C, Duan C, Liu Q, Miao ZR, Li SM, Ling F. Accurate assesment of the diagnosis between 50-69% and 70-99% carotid stenoses with ultrasonography. Chinese Journal of Cerebrovascular Diseases. 3(5): 211-218,2006.
Meng XF, Hua Y, Liu BB, Ling C, Miao ZR, Jiao LQ. The diagnostic accuracy of transcranial doppler ultrasonogrphy for middle cerebral artery stenosis. Chinese Journal of Cerebrovascular Diseases. 7(6): 284-289, 2010.
Liu R, Gao M, Zhao X. Evaluation of collateral circulation in patients with internal carotid artery occlusion: A clinical and ultrasonographic multicenter study. Vasc Med. 2024 Dec;29(6):707-715. doi: 10.1177/1358863X241264759. Epub 2024 Sep 8.
PubMed 39245861
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Carotid Artery and Intracranial Arteries by Ultrasound in Chinese Population With Transient Ischemic Attack and Ischemic Stroke: a Multi-center Registry Study
- ClinicalTrials.gov ID
- NCT02397655
- Acronym / sponsor ID
- VUS-ICVD
- Conditions
- Stroke
- Keywords
- stroke, ischemia, atherosclerosis, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,012 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Shanxi Medical University, Liaocheng Brains Hospital, Tianjin Huanhu Hospital, Baotou Central Hospital, The First Hospital of Jilin University, First Affiliated Hospital of Harbin Medical University, First Hospital of China Medical University, LanZhou University, First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Soochow University, Anhui Provincial Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, ZhuHai Hospital, Fujian Provincial Hospital, Mianyang Central Hospital, The Second Affiliated Hospital of Kunming Medical University, Brains Hospital of Hunan Province, Henan Provincial People's Hospital, Luoyang Central Hospital, National Health and Family Planning Commission Stroke Prevention Engineering Committee, Dalian Municipal Central Hospital
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Posted 4 Nov 2016
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 this multicenter study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations with transient ischemic attack and ischemic stroke and analyze the influencing factors of atherosclerosis distribution pattern.
Detailed description
In this multicenter study, carotid artery color doppler flow imaging and transcranial color code doppler or transcranial doppler will be used to screen the extra-/intra-cranial vessels in chinese populations with transient ischemic attack and ischemic stroke. The aim of this study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations and analyze the influencing factors of atherosclerosis distribution pattern.
- Ultrasound examinations procedures: According to the guidelines of vascular ultrasonography published by the Chinese Medical Doctor Association (CMDA) in 2009. The stenosis degrees of carotid artery, vertebral artery, subclavian artery as well as the middle cerebral artery are evaluated followed the criteria we published previously (references 1-4).
- Radiology examinations procedures: Enrolled patients receive CT or MRI examinations to determine the presence and the location of cerebral infarction. If necessary, patients receive CT angiography (CTA) or MRI angiography (MRA) examinations to confirm the degrees of vessel stenosis.
- The data collected in this study including:
- The general informations of enrolled subjects, which include name, gender, age, resident address, telephone number.Each subject is assigned an unique identification number.
- The history of stroke risk factors, which include 1) hypertension; 2) atrial fibrillation; 3) smoking; 4) dyslipidemia; 5) diabetes mellitus; 6) lack of physical activity (the standard of physical activity is ≥ 3 times per week and ≥30 min per time and the duration time ≥ 1 year);7) obvious overweight or obesity (BMI ≥ 26.0 Kg/m2);8) with family history of stroke.
- The medicines used within recent 2 weeks, the surgery name (such as stenting, carotid endarterectomy)if any.
- The results of vascular ultrasonography, ultrasonic cardiogram, radiology examinations, laboratory tests results (blood glucose, lipoproteins pattern, homocystein, C reactive protein, fibrinogen)
- Statistic analysis plans The Statistical Package for Social Sciences (SPSS version 22.0) software was used for the statistical analyses.
- Numerical values are shown as the mean ± standard deviation (SD). The t test or One-way ANOVA is used to compare the numerical values among different groups.
- Chi square test is used to analyze the influencing factors on the intra-/extra-cranial atherosclerosis distribution patterns and the relationship between vessel stenosis degrees and the occurence of ischemic stroke.
- Logistic regression is used to analyze the influencing intensity of various risk factors on atherosclerosis and ischemic events.
- A P value <0.05 was considered statistically significant.
- Quality assurance plans:
- The medical centers implement the projects are the stroke prevention and treatment base hospitals awarded by National Health and Family Planning Commission, P.R. China. The medical centers have the instruments required in this study.
- Neurologists, neurosurgeons and vascular ultrasound physicians have received standard training hosted by National Health and Family Planning Commission stroke prevention engineering committee and obtained excellent records.
- All the centers conduct the project followed the uniform implementation plans and each center guarantee the data input in time and accurately.
- The project has the unique database and data input in uniform format.
- There are specific staffs to check the accuracy and completeness of data.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In hospital patients with transient ischemic attack and ischemic stroke.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- cerebral hemorrhage;
- vessel stenosis or occlusion caused by trauma,dissection or Takayasu's arteritis；
- Stroke patients caused by patent foramen ovale.
- Moyamoya disease;
- Multiple sclerosis;
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
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography
Time frame: 30 days after subjects recruitment
By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, <50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion. By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion. Patients with one of the above arteries having >50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21276651Hua Y, Jia L, Li L, Ling C, Miao Z, Jiao L. Evaluation of severe subclavian artery stenosis by color Doppler flow imaging. Ultrasound Med Biol. 2011 Mar;37(3):358-63. doi: 10.1016/j.ultrasmedbio.2010.12.003. Epub 2011 Jan 26.
- Background: PubMed 19843764Hua Y, Meng XF, Jia LY, Ling C, Miao ZR, Ling F, Liu JB. Color Doppler imaging evaluation of proximal vertebral artery stenosis. AJR Am J Roentgenol. 2009 Nov;193(5):1434-8. doi: 10.2214/AJR.09.2624.
- BackgroundHua Y, Liu BB, Ling C, Duan C, Liu Q, Miao ZR, Li SM, Ling F. Accurate assesment of the diagnosis between 50-69% and 70-99% carotid stenoses with ultrasonography. Chinese Journal of Cerebrovascular Diseases. 3(5): 211-218,2006.
- BackgroundMeng XF, Hua Y, Liu BB, Ling C, Miao ZR, Jiao LQ. The diagnostic accuracy of transcranial doppler ultrasonogrphy for middle cerebral artery stenosis. Chinese Journal of Cerebrovascular Diseases. 7(6): 284-289, 2010.
- Derived from this study: PubMed 39245861Liu R, Gao M, Zhao X. Evaluation of collateral circulation in patients with internal carotid artery occlusion: A clinical and ultrasonographic multicenter study. Vasc Med. 2024 Dec;29(6):707-715. doi: 10.1177/1358863X241264759. Epub 2024 Sep 8.
- Individual participant dataSharing planned: No
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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.
Yang Hua, MD principal investigator
No.45, Changchun Road, Xicheng District, Beijing, China 100053
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 Stroke, run by Xuanwu Hospital, Beijing 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 0 inclusion and 6 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 4 Nov 2016. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography (time frame: 30 days after subjects recruitment). 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 NCT02397655, which also lists 5 linked publications.
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 4 Nov 2016.