Ischemic StrokeCARE-IINCT02017756
Chinese Atherosclerosis Risk Evaluation- Phase II
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Tsinghua University at 14 sites in China.
Trial summary
Stroke is the first and the fourth leading cause of death in the United States and China, respectively. Disruption of cerebrovascular vulnerable atherosclerotic plaque is the major etiology of ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack, Carotid Atherosclerotic Disease
- How many people
- 1,000 participants
- Where
- 14 sitesChina
- Study dates
- Jan 2012to Dec 2014
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, we plan to recruit patients with recent TIA of ischemic stroke (within 2 weeks) and carotid atherosclerotic plaque determined by ultrasound. The patients will be recruited from more than 10 hospitals in different areas of China.
Who may be able to join
- Patients with recent TIA of ischemic stroke (2 weeks) and carotid plaque determined by ultrasound will be included in this study.
Who cannot join
- Patients with contraindications to MR scan
- Patients with hemorrhagic stroke
- Patients with evidence of cardiogenic stroke
- Patients with brain tumors
- Patients underwent carotid revascularization therapy, such as stenting and endarterectomy
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Department of Radiology, Peking University First Hospital
Beijing, 100034
Feiyu Li, MD, PhD, 8613552292893, redwindowlfy@163.com
Xiaoying Wang, MD, PhD
- Recruiting
Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
Beijing, 100084
Le He, MD, 861062796175, hele0806@aliyun.com
Xihai Zhao, MD, PhD
- Recruiting
Department of Radiology, Beijing Hospital
Beijing, 100730
Yan Song, MD, PhD, 8618610566272, songyan@u.washington.edu
Min Chen, MD, PhD
- Recruiting
Department of Radiology, PLA General Hospital
Beijing, 100853
Xu Han, MD, 8613810139203, hxlryt@126.com
Jianming Cai, MD, PhD
- Recruiting
Department of Radiology, Fujian Medical University Union Hospital
Fuzhou, 350001
Yunjing Xue, MD, PhD, 8613950497808, xueyunjing@126.com
Qing Duan, MD
- Recruiting
Department of Radiology, Sun Yat-Sen Memorial Hospital
Guangzhou, 510120
Mingwei Xie, MD, 15018722452, 553614809@qq.com
Biling Liang, MD
- Recruiting
Department of Radiology, Zhujiang Hospital of Southern Medical University
Guangzhou, 510282
Jing Zhang, MD, 8615521118683, zzjing881205@163.com
Zhibo Wen, MD
- Recruiting
Department of Radiology, Harbin University The Fourth Affiliated Hospital
Harbin, 150001
Yang Ji, MD, 8613654557419, jiyang19871104@126.com
Dan Wang, MD
- Recruiting
Shandong Medical Imaging Research Institute
Jinan, 250021
Honglu Shi, MD, 15053177828, shlkb08@163.com
Guangbin Wang, MD, PhD
- Recruiting
Department of Radiology, Nanjing Drum Tower Hospital
Nanjing, 210008
Maoxue Wang, MD, 8615851803070, fmriwangmx@126.com
Bing Zhang, MD, PhD
- Recruiting
Department of Radiology, The First Hospital of Qiqihaer City
Qiqihar, 161005
Zhong Zhuang, MD, 8618245281102, zz_15880732@126.com
Xiaogang Peng, MD
- Recruiting
Department of Radiology, Shanghai Renji Hospital
Shanghai, 200127
Huilin Zhao, MD, 8613918666437, huilinzhao2013@163.com
Jianrong Xu, MD, PhD
- Recruiting
Department of Radiology, Tianjin Fourth Centre Hospital
Tianjin, 300140
Xiao Gao, MD, 13920924729, 03092901010@163.com
Shengzhang Ji, MD
- Recruiting
Department of Radiology, Qinghai University Affiliated Hospital
Xining, 810001
Yuntai Cao, MD, 8615003666895, caoyuntai04@126.com
Haihua Bao, MD
About this study
Official title: A Phase II Study of Chinese Atherosclerosis Risk Evaluation: Investigation of Carotid Atherosclerotic Disease in Patients With Ischemic Cerebrovascular Events
Stroke is the first and the fourth leading cause of death in the United States and China, respectively. Disruption of cerebrovascular vulnerable atherosclerotic plaque is the major etiology of ischemic stroke. Therefore, early detection and treatment of vulnerable plaques occurring at the feeding arteries to brain (cerebral arteries) will be helpful for prevention of stroke.
Atherosclerosis is a systemic disease that usually affects multiple vascular beds. Previous studies have shown that these high risk lesions in different segments of cerebral arteries (intracranial and extracranial arteries) might be racially specific. It is reported that, in stroke patients, intracranial vulnerable plaques are prevalent in Asian populations whereas atherosclerosis more frequently involves extracranial carotid arteries in American subjects. However, these findings are based on angiographic imaging approaches via measuring arterial luminal stenosis. Because the atherosclerotic plaque often appears as outward expansion, namely positive remodeling during progression, measuring luminal stenosis will underestimate the disease severity. Hence, directly viewing the plaque in the vessel wall is strongly suggested in order to objectively evaluate the cerebrovascular vulnerable plaque.
Read more
High resolution, black-blood magnetic resonance (MR) imaging has been widely used to accurately characterize carotid vulnerable plaque in the last two decades. The aim of using MR black-blood techniques is to suppress the blood signal (black) to enhance the signal contrast between the vessel wall and blood in the arterial lumen. Excellent agreement has been achieved between MR imaging and histology in identification of plaque components, such as intraplaque hemorrhage and lipid core. For assessing carotid plaque, MR imaging is superior to computed tomography and ultrasound imaging techniques due to its advantages including noninvasive imaging, lack of ionizing radiation, excellent soft tissue resolution, and multi-parametric image acquisition.
The Investigators hypothesize that there are specific characteristics in carotid vulnerable plaques in Chinese patients with ischemic cerebrovascular events such as ischemic stroke and transient ischemic attack (TIA). This study seeks to investigate the characteristics of vulnerable plaque in carotid arteries using high resolution, black-blood MR imaging in patients with recent TIA or ischemic stroke.
This is a cross-sectional, multicenter study. A total of 1000 patients will be recruited from more than 10 different hospitals across China within 3 years. All patients will undergo MR imaging for brain and carotid arteries within two weeks after symptom onset. The prevalence of carotid vulnerable plaque and its correlations with brain ischemic lesions, traditional risk factors, and regional distribution of China will be determined.
- Keywords
- Carotid artery, Atherosclerosis, Vulnerable plaque, Magnetic resonance imaging, Arterial wall
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Carotid Artery Diseases, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of carotid vulnerable plaques, defined as lesions with intraplaque hemorrhage, fibrous cap rupture, or lipid core occupying >40% of vessel wall area as determined by high resolution, black-blood MR imaging in this study population.
Measured: within two weeks after symptom onset
Secondary outcomes (3)
Carotid wall and brain infarct measurements.
The following features will be measured: carotid mean wall thickness, normalized wall index, and incidence of compositional features (calcification, lipid core, intraplaque hemorrhage, cap rupture) and volume of cerebral white matter lesions or infarcts.
These measurements will be used to determine the relationship of carotid wall features with the volume of cerebral white matter lesions or infarcts.
Measured: within two weeks after symptom onset
Traditional risk factors.
Traditional risk factors will be collected from subjects including: age, gender, hypertension, smoke, diabetes, and history of cardiovascular disease. The association of the volume and incidence of carotid plaque calcification, lipid core, and intraplaque hemorrhage with traditional risk factors will be evaluated.
Measured: within two weeks after symptom onset
Incidence and volume of carotid plaques and geographic region of subjects.
The incidence and the volume of carotid plaque calcification, lipid core, and intraplaque hemorrhage will be measured and collected. Data on geographic region of subjects in China, such as Northeast, North, East, South, and Western areas will be collected. This data will be used to study compare incidence and volume of carotid plaque features with geographic regions of subjects.
Measured: within two weeks after symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Yuan, Tsinghua University
- Investigators
- Chun Yuan, PhD, Principal investigator, Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017756
- Sponsor's protocol ID
- Tsinghua-985
- Acronym
- CARE-II
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3.
PubMed 22052510Wong KS, Li H, Chan YL, Ahuja A, Lam WW, Wong A, Kay R. Use of transcranial Doppler ultrasound to predict outcome in patients with intracranial large-artery occlusive disease. Stroke. 2000 Nov;31(11):2641-7. doi: 10.1161/01.str.31.11.2641.
PubMed 11062288Saam T, Underhill HR, Chu B, Takaya N, Cai J, Polissar NL, Yuan C, Hatsukami TS. Prevalence of American Heart Association type VI carotid atherosclerotic lesions identified by magnetic resonance imaging for different levels of stenosis as measured by duplex ultrasound. J Am Coll Cardiol. 2008 Mar 11;51(10):1014-21. doi: 10.1016/j.jacc.2007.10.054.
PubMed 18325441Glagov S, Weisenberg E, Zarins CK, Stankunavicius R, Kolettis GJ. Compensatory enlargement of human atherosclerotic coronary arteries. N Engl J Med. 1987 May 28;316(22):1371-5. doi: 10.1056/NEJM198705283162204.
PubMed 3574413Cai JM, Hatsukami TS, Ferguson MS, Small R, Polissar NL, Yuan C. Classification of human carotid atherosclerotic lesions with in vivo multicontrast magnetic resonance imaging. Circulation. 2002 Sep 10;106(11):1368-73. doi: 10.1161/01.cir.0000028591.44554.f9.
PubMed 12221054Yuan C, Mitsumori LM, Ferguson MS, Polissar NL, Echelard D, Ortiz G, Small R, Davies JW, Kerwin WS, Hatsukami TS. In vivo accuracy of multispectral magnetic resonance imaging for identifying lipid-rich necrotic cores and intraplaque hemorrhage in advanced human carotid plaques. Circulation. 2001 Oct 23;104(17):2051-6. doi: 10.1161/hc4201.097839.
PubMed 11673345Saam T, Cai JM, Cai YQ, An NY, Kampschulte A, Xu D, Kerwin WS, Takaya N, Polissar NL, Hatsukami TS, Yuan C. Carotid plaque composition differs between ethno-racial groups: an MRI pilot study comparing mainland Chinese and American Caucasian patients. Arterioscler Thromb Vasc Biol. 2005 Mar;25(3):611-6. doi: 10.1161/01.ATV.0000155965.54679.79. Epub 2005 Jan 13.
PubMed 15653565Shao S, Sun Y, Shi H, Li R, Sun Q, Yao B, Watase H, Hippe DS, Yuan C, Wang G, Zhang Q, Zhao X; Investigators of CARE-II Study. Metabolically Abnormal Obesity and Carotid Plaque Vulnerability: A Vessel Wall MRI Study Linking Obesity Phenotypes to Atherosclerotic Instability. Arterioscler Thromb Vasc Biol. 2025 Nov;45(11):2097-2108. doi: 10.1161/ATVBAHA.125.323413. Epub 2025 Sep 18.
PubMed 40964717Meddings Z, Rundo L, Sadat U, Zhao X, Teng Z, Graves MJ. Robustness and classification capabilities of MRI radiomic features in identifying carotid plaque vulnerability. Br J Radiol. 2024 May 29;97(1158):1118-1124. doi: 10.1093/bjr/tqae057.
PubMed 38711198Shao S, Shi H, Wang G, Li R, Sun Q, Yao B, Watase H, Hippe DS, Yuan C, Zhao X; Investigators of CARE-II study. Differences in left and right carotid plaque vulnerability in patients with bilateral carotid plaques: a CARE-II study. Stroke Vasc Neurol. 2023 Aug;8(4):284-291. doi: 10.1136/svn-2022-001937. Epub 2023 Jan 3.
PubMed 36596656Baylam Geleri D, Watase H, Chu B, Chen L, Zhao H, Zhao X, Hatsukami TS, Yuan C; CARE-II Study Collaborators. Detection of Advanced Lesions of Atherosclerosis in Carotid Arteries Using 3-Dimensional Motion-Sensitized Driven-Equilibrium Prepared Rapid Gradient Echo (3D-MERGE) Magnetic Resonance Imaging as a Screening Tool. Stroke. 2022 Jan;53(1):194-200. doi: 10.1161/STROKEAHA.120.032505. Epub 2021 Sep 30.
PubMed 34587796Jiang C, Zhang J, Zhu J, Wang X, Wen Z, Zhao X, Yuan C; CARE-II Investigators. Association between coexisting intracranial artery and extracranial carotid artery atherosclerotic diseases and ipsilateral cerebral infarction: a Chinese Atherosclerosis Risk Evaluation (CARE-II) study. Stroke Vasc Neurol. 2021 Dec;6(4):595-602. doi: 10.1136/svn-2020-000538. Epub 2021 Apr 26.
PubMed 33903178Yang D, Ji Y, Wang D, Watase H, Hippe DS, Zhao X, Yuan C. Comparison of carotid atherosclerotic plaques between subjects in Northern and Southern China: a Chinese atherosclerosis risk evaluation study. Stroke Vasc Neurol. 2020 Jun;5(2):138-145. doi: 10.1136/svn-2019-000288. Epub 2020 Jan 29.
PubMed 32404502Liu Y, Wang M, Zhang B, Wang W, Xu Y, Han Y, Yuan C, Zhao X. Size of carotid artery intraplaque hemorrhage and acute ischemic stroke: a cardiovascular magnetic resonance Chinese atherosclerosis risk evaluation study. J Cardiovasc Magn Reson. 2019 Jul 1;21(1):36. doi: 10.1186/s12968-019-0548-1.
PubMed 31262337Zhou C, Yuan C, Li R, Wang W, Li C, Zhao X; CARE-II Study Collaborators. Association Between Incomplete Circle of Willis and Carotid Vulnerable Atherosclerotic Plaques. Arterioscler Thromb Vasc Biol. 2018 Nov;38(11):2744-2749. doi: 10.1161/ATVBAHA.118.311797.
PubMed 30354232
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Chinese Atherosclerosis Risk Evaluation: Investigation of Carotid Atherosclerotic Disease in Patients With Ischemic Cerebrovascular Events
- ClinicalTrials.gov ID
- NCT02017756
- Acronym / sponsor ID
- CARE-II / Tsinghua-985
- Keywords
- Carotid artery, Atherosclerosis, Vulnerable plaque, Magnetic resonance imaging, Arterial wall
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Dec 2013 (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.
Stroke is the first and the fourth leading cause of death in the United States and China, respectively. Disruption of cerebrovascular vulnerable atherosclerotic plaque is the major etiology of ischemic stroke. Therefore, early detection and treatment of vulnerable plaques occurring at the feeding arteries to brain (cerebral arteries) will be helpful for prevention of stroke.
Atherosclerosis is a systemic disease that usually affects multiple vascular beds. Previous studies have shown that these high risk lesions in different segments of cerebral arteries (intracranial and extracranial arteries) might be racially specific. It is reported that, in stroke patients, intracranial vulnerable plaques are prevalent in Asian populations whereas atherosclerosis more frequently involves extracranial carotid arteries in American subjects. However, these findings are based on angiographic imaging approaches via measuring arterial luminal stenosis. Because the atherosclerotic plaque often appears as outward expansion, namely positive remodeling during progression, measuring luminal stenosis will underestimate the disease severity. Hence, directly viewing the plaque in the vessel wall is strongly suggested in order to objectively evaluate the cerebrovascular vulnerable plaque.
High resolution, black-blood magnetic resonance (MR) imaging has been widely used to accurately characterize carotid vulnerable plaque in the last two decades. The aim of using MR black-blood techniques is to suppress the blood signal (black) to enhance the signal contrast between the vessel wall and blood in the arterial lumen. Excellent agreement has been achieved between MR imaging and histology in identification of plaque components, such as intraplaque hemorrhage and lipid core. For assessing carotid plaque, MR imaging is superior to computed tomography and ultrasound imaging techniques due to its advantages including noninvasive imaging, lack of ionizing radiation, excellent soft tissue resolution, and multi-parametric image acquisition.
The Investigators hypothesize that there are specific characteristics in carotid vulnerable plaques in Chinese patients with ischemic cerebrovascular events such as ischemic stroke and transient ischemic attack (TIA). This study seeks to investigate the characteristics of vulnerable plaque in carotid arteries using high resolution, black-blood MR imaging in patients with recent TIA or ischemic stroke.
This is a cross-sectional, multicenter study. A total of 1000 patients will be recruited from more than 10 different hospitals across China within 3 years. All patients will undergo MR imaging for brain and carotid arteries within two weeks after symptom onset. The prevalence of carotid vulnerable plaque and its correlations with brain ischemic lesions, traditional risk factors, and regional distribution of China will be determined.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, we plan to recruit patients with recent TIA of ischemic stroke (within 2 weeks) and carotid atherosclerotic plaque determined by ultrasound. The patients will be recruited from more than 10 hospitals in different areas of China.
Key inclusion criteria (1 listed)
- Patients with recent TIA of ischemic stroke (2 weeks) and carotid plaque determined by ultrasound will be included in this study.
Key exclusion criteria (5 listed)
- Patients with contraindications to MR scan
- Patients with hemorrhagic stroke
- Patients with evidence of cardiogenic stroke
- Patients with brain tumors
- Patients underwent carotid revascularization therapy, such as stenting and endarterectomy
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
Prevalence of carotid vulnerable plaques, defined as lesions with intraplaque hemorrhage, fibrous cap rupture, or lipid core occupying >40% of vessel wall area as determined by high resolution, black-blood MR imaging in this study population.
Time frame: within two weeks after symptom onset
3 secondary outcomes
Carotid wall and brain infarct measurements.
Time frame: within two weeks after symptom onset
Traditional risk factors.
Time frame: within two weeks after symptom onset
Incidence and volume of carotid plaques and geographic region of subjects.
Time frame: within two weeks after symptom onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
- Background: PubMed 22052510Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3.
- Background: PubMed 11062288Wong KS, Li H, Chan YL, Ahuja A, Lam WW, Wong A, Kay R. Use of transcranial Doppler ultrasound to predict outcome in patients with intracranial large-artery occlusive disease. Stroke. 2000 Nov;31(11):2641-7. doi: 10.1161/01.str.31.11.2641.
- Background: PubMed 18325441Saam T, Underhill HR, Chu B, Takaya N, Cai J, Polissar NL, Yuan C, Hatsukami TS. Prevalence of American Heart Association type VI carotid atherosclerotic lesions identified by magnetic resonance imaging for different levels of stenosis as measured by duplex ultrasound. J Am Coll Cardiol. 2008 Mar 11;51(10):1014-21. doi: 10.1016/j.jacc.2007.10.054.
- Background: PubMed 3574413Glagov S, Weisenberg E, Zarins CK, Stankunavicius R, Kolettis GJ. Compensatory enlargement of human atherosclerotic coronary arteries. N Engl J Med. 1987 May 28;316(22):1371-5. doi: 10.1056/NEJM198705283162204.
- Background: PubMed 12221054Cai JM, Hatsukami TS, Ferguson MS, Small R, Polissar NL, Yuan C. Classification of human carotid atherosclerotic lesions with in vivo multicontrast magnetic resonance imaging. Circulation. 2002 Sep 10;106(11):1368-73. doi: 10.1161/01.cir.0000028591.44554.f9.
- Background: PubMed 11673345Yuan C, Mitsumori LM, Ferguson MS, Polissar NL, Echelard D, Ortiz G, Small R, Davies JW, Kerwin WS, Hatsukami TS. In vivo accuracy of multispectral magnetic resonance imaging for identifying lipid-rich necrotic cores and intraplaque hemorrhage in advanced human carotid plaques. Circulation. 2001 Oct 23;104(17):2051-6. doi: 10.1161/hc4201.097839.
- Background: PubMed 15653565Saam T, Cai JM, Cai YQ, An NY, Kampschulte A, Xu D, Kerwin WS, Takaya N, Polissar NL, Hatsukami TS, Yuan C. Carotid plaque composition differs between ethno-racial groups: an MRI pilot study comparing mainland Chinese and American Caucasian patients. Arterioscler Thromb Vasc Biol. 2005 Mar;25(3):611-6. doi: 10.1161/01.ATV.0000155965.54679.79. Epub 2005 Jan 13.
- Derived from this study: PubMed 40964717Shao S, Sun Y, Shi H, Li R, Sun Q, Yao B, Watase H, Hippe DS, Yuan C, Wang G, Zhang Q, Zhao X; Investigators of CARE-II Study. Metabolically Abnormal Obesity and Carotid Plaque Vulnerability: A Vessel Wall MRI Study Linking Obesity Phenotypes to Atherosclerotic Instability. Arterioscler Thromb Vasc Biol. 2025 Nov;45(11):2097-2108. doi: 10.1161/ATVBAHA.125.323413. Epub 2025 Sep 18.
- Derived from this study: PubMed 38711198Meddings Z, Rundo L, Sadat U, Zhao X, Teng Z, Graves MJ. Robustness and classification capabilities of MRI radiomic features in identifying carotid plaque vulnerability. Br J Radiol. 2024 May 29;97(1158):1118-1124. doi: 10.1093/bjr/tqae057.
- Derived from this study: PubMed 36596656Shao S, Shi H, Wang G, Li R, Sun Q, Yao B, Watase H, Hippe DS, Yuan C, Zhao X; Investigators of CARE-II study. Differences in left and right carotid plaque vulnerability in patients with bilateral carotid plaques: a CARE-II study. Stroke Vasc Neurol. 2023 Aug;8(4):284-291. doi: 10.1136/svn-2022-001937. Epub 2023 Jan 3.
- Derived from this study: PubMed 34587796Baylam Geleri D, Watase H, Chu B, Chen L, Zhao H, Zhao X, Hatsukami TS, Yuan C; CARE-II Study Collaborators. Detection of Advanced Lesions of Atherosclerosis in Carotid Arteries Using 3-Dimensional Motion-Sensitized Driven-Equilibrium Prepared Rapid Gradient Echo (3D-MERGE) Magnetic Resonance Imaging as a Screening Tool. Stroke. 2022 Jan;53(1):194-200. doi: 10.1161/STROKEAHA.120.032505. Epub 2021 Sep 30.
- Derived from this study: PubMed 33903178Jiang C, Zhang J, Zhu J, Wang X, Wen Z, Zhao X, Yuan C; CARE-II Investigators. Association between coexisting intracranial artery and extracranial carotid artery atherosclerotic diseases and ipsilateral cerebral infarction: a Chinese Atherosclerosis Risk Evaluation (CARE-II) study. Stroke Vasc Neurol. 2021 Dec;6(4):595-602. doi: 10.1136/svn-2020-000538. Epub 2021 Apr 26.
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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.
Chun Yuan, PhD principal investigator
Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Tsinghua University at 14 sites 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xihai Zhao, MD, PhD (861062792662, xihaizhao@tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of carotid vulnerable plaques, defined as lesions with intraplaque hemorrhage, fibrous cap rupture, or lipid core occupying >40% of vessel wall area as determined by high resolution, black-blood MR imaging in this study population. (time frame: within two weeks after symptom onset). 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 NCT02017756, which also lists 17 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 23 Dec 2013.