Intracranial AtherosclerosisNCT02719652
Vessel Wall and Perfusion Imaging in Intracranial Atherosclerosis
An observational study of Intracranial Atherosclerosis, run by Xiuhai Guo at 1 site in China.
Trial summary
Intracranial atherosclerotic disease (ICAD) is an important cause of ischemic stroke. The occurrence of stroke caused by symptomatic ICAD is significantly different compared with asymptomatic ICAD (19% vs 3.5%), suggesting that plaque vulnerability may be responsible for the difference. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Atherosclerosis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Sep 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with significant MCA stenosis（≥50%）on TCD, MRA, and/or CTA together with one or more risk factors of atherosclerosis will be prospectively recruited. Symtomatic patients will be included if they had suffered from a recent transient ischemic attack or ischemic stroke(NHISS≤6) in the territory of the stenotic MCA. Asymptomatic patients will be included if they had no history of cerebrovascular events or a history of an ischemic event in a territory outside that the affected MCA.
Who may be able to join
- Symptomatic patients who suffered TIA or non-severe ischemic stroke(NHISS ≤6) in one week with 50% to 90% stenosis of MCA.
- Asymptomatic patients with ≥50% MCA stenosis without history of cerebrovascular events or an ischemic event in a territory outside that supplied by the affected MCA.
- Degree of ≥50% stenosis must be conformed by MRA, CTA and/or TCD.
- Age: 18-80 years.
- mRS scale score of ≤2.
- Patients who agree with future follow-up visits.
- Patients who sign the informed consent.
Who cannot join
- Coexistent ipsilateral internal carotid stenosis（≥50%）on MRA, CTA and/or TCD. Non-atherosclerotic vasculopathy, such as dissection, vasculitis,or moyamoya disease.
- Evidence of cardioembolism, such as atrial fibrillation, mechanical prosthetic valve disease, sick sinus syndrome, dilated cardiomyopathy, left ventricular thrombus, or recent myocardial infarction, hemorrhage, watershed infarction, or other cerebral diseases, such as vascular malformation, neoplasms, and encephalopyosis.
- Patients who are unable to undergo HR-MRI owing to underlying medical conditions.
- Patients who are allergic to any of the study medications, including aspirin, clopidogrel,atorvastatin,or rosuvastatin.
Trial locations and contacts
1 site in 1 country.
Xiuhai Guo, MD contact
Qi Yang, MD contact
China1 site, 1 recruiting
- Recruiting
Department of Neurology, Xuanwu hospital
Beijing, Beijing Municipality, 100053
Xiuhai Guo, MD, guoxhxuan@126.com
Qi Yang, MD, 86-18910766178, yangyangqiqi@gmail.com
About this study
Intracranial atherosclerotic disease (ICAD) is an important cause of ischemic stroke. The occurrence of stroke caused by symptomatic ICAD is significantly different compared with asymptomatic ICAD (19% vs 3.5%), suggesting that plaque vulnerability may be responsible for the difference. Based on the previous high-resolution magnetic resonance vessel wall imaging (HR-MRI) results, the investigators hypothesis that the feature of intracranial plaque enhancement is an important imaging biomarker of plaque instability, which is closely related to stroke. The investigators will establish the ICAD cohort and use HR-MRI to investigate the composition, morphology and the enhancement pattern of symptomatic ICAD plaques. These findings will correlate with biochemical markers, and stroke recurrence, in order to explore:
- plaque characteristics and the enhancement features between symptomatic ICAD and asymptomatic ICAD
- the relationship between plaque enhancement and the composition of plaques;
- relationship among enhancement features of symptomatic ICAD plaques, biomarkers with different clinical significance,
- evolution of enhancement features of symptomatic ICAD plaques under intensive medical therapy.
The investigators aim to explore the correlation between vulnerable plaque stratification and clinical outcomes, to explore the value of vascular responses in the pathogenicity of ICAD vulnerable plaques, as well as to provide objective basis for the establishment of the evaluation criteria of intracranial atherosclerotic vulnerable plaques.
Read the detailed description
Detailed description:
Title: Vessel wall and Perfusion Imaging in Intracranial Atherosclerosis
Design: This is an prospective study that will study the characteristics of intracranial atherosclerotic plaque and the enhancement features of symptomatic ICAD during a mean follow-up of 1 year in symptomatic or asymtomatic patients with moderate to severe stenosis of middle cerebral artery(MCA).
In the WASID trail,patients with at least 70% stenosis of a major intracranial artery had an increased risk of recurrent stroke. However,The degree of stenosis is no longer the single predictor of vulnerable atherosclerotic lesions. Vulnerable plaques are closely associated with stroke recurrence.With the development of neurologic imaging, HR-MRI has unique ability to provide information on plaque compositions, plaque burden and vulnerable features. Several recent investigations suggest that enhancement of intracranial plaque is associated with recurrent stroke. However, no corhort study has been performed.
This prospective, multicenter trail will be conducted in China. Based on the previous work,participants will be divided into two groups :symtomatic ICAD and asymtomatic ICAD. Neurological examination and clinical sera testing will be performed at baseline, 1 month, 3 months, 6 months, and 12 months.The stroke incidence rate of asymptomatic ICAD and stroke recurrence rate of symptomatic ICAD will be recorded.
- Conditions
- Intracranial Atherosclerosis
- Keywords
- intracranial atherosclerotic disease（ICAD）, vulnerable plaque, high-resolution magnetic resonance imaging （HR-MRI）
- Medical subject headings
- Intracranial Arteriosclerosis
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 |
|---|---|---|
| symptomatic ICAD | symptomatic intracranial atherosclerosis diseases | |
| asymptomatic ICAD | asymptomatic intracranial atherosclerosis diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke recurrence
the number of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the stenotic MCA.
Measured: 1 year
Secondary outcomes (3)
Death
The number of participants who suffer from death after enrollment
Measured: 1 year
Any stroke, severe transient ischemic attack (TIA) outside the territory of symptomatic MCA
The number of participants who suffer from any stroke, severe transient ischemic attack (TIA) outside the territory of symptomatic MCA
Measured: at 7 days, 30 days,3 months，6 months, 12 months
Stroke of asymptomatic participants
The number of asymptomatic participants who suffer from stroke after enrollment in the territory of the stenotic MCA；
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 posted25 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intracranial AtherosclerosisStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiuhai Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiuhai Guo, Capital Medical University
- Investigators
- Guo Xiuhai, MD, Principal investigator, Xuanwu Hospital, Capital Medical University, Beijing, ChinaQi Yang, MD, Principal investigator, Xuanwu Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719652
- Sponsor's protocol ID
- ICAD-001
- Status last verified
- Mar 2016
- First submitted
- 16 Mar 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The date of individual participant will be recorded in case report form(CRF),which will be stored technically
Publications
Mossa-Basha M, Hwang WD, De Havenon A, Hippe D, Balu N, Becker KJ, Tirschwell DT, Hatsukami T, Anzai Y, Yuan C. Multicontrast high-resolution vessel wall magnetic resonance imaging and its value in differentiating intracranial vasculopathic processes. Stroke. 2015 Jun;46(6):1567-73. doi: 10.1161/STROKEAHA.115.009037. Epub 2015 May 7.
PubMed 25953365Ahn SH, Lee J, Kim YJ, Kwon SU, Lee D, Jung SC, Kang DW, Kim JS. Isolated MCA disease in patients without significant atherosclerotic risk factors: a high-resolution magnetic resonance imaging study. Stroke. 2015 Mar;46(3):697-703. doi: 10.1161/STROKEAHA.114.008181. Epub 2015 Jan 27.
PubMed 25628303Ryoo S, Cha J, Kim SJ, Choi JW, Ki CS, Kim KH, Jeon P, Kim JS, Hong SC, Bang OY. High-resolution magnetic resonance wall imaging findings of Moyamoya disease. Stroke. 2014 Aug;45(8):2457-60. doi: 10.1161/STROKEAHA.114.004761. Epub 2014 Jun 19.
PubMed 24947295Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
PubMed 24135208Vakil P, Vranic J, Hurley MC, Bernstein RA, Korutz AW, Habib A, Shaibani A, Dehkordi FH, Carroll TJ, Ansari SA. T1 gadolinium enhancement of intracranial atherosclerotic plaques associated with symptomatic ischemic presentations. AJNR Am J Neuroradiol. 2013 Dec;34(12):2252-8. doi: 10.3174/ajnr.A3606. Epub 2013 Jul 4.
PubMed 23828109
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vessel Wall and Perfusion Imaging in Intracranial Atherosclerosis
- ClinicalTrials.gov ID
- NCT02719652
- Acronym / sponsor ID
- ICAD-001
- Conditions
- Intracranial Atherosclerosis
- Keywords
- intracranial atherosclerotic disease（ICAD）, vulnerable plaque, high-resolution magnetic resonance imaging （HR-MRI）
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xiuhai GuoUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 25 Mar 2016 (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.
Intracranial atherosclerotic disease (ICAD) is an important cause of ischemic stroke. The occurrence of stroke caused by symptomatic ICAD is significantly different compared with asymptomatic ICAD (19% vs 3.5%), suggesting that plaque vulnerability may be responsible for the difference. Based on the previous high-resolution magnetic resonance vessel wall imaging (HR-MRI) results, the investigators hypothesis that the feature of intracranial plaque enhancement is an important imaging biomarker of plaque instability, which is closely related to stroke. The investigators will establish the ICAD cohort and use HR-MRI to investigate the composition, morphology and the enhancement pattern of symptomatic ICAD plaques. These findings will correlate with biochemical markers, and stroke recurrence, in order to explore:
- plaque characteristics and the enhancement features between symptomatic ICAD and asymptomatic ICAD
- the relationship between plaque enhancement and the composition of plaques;
- relationship among enhancement features of symptomatic ICAD plaques, biomarkers with different clinical significance,
- evolution of enhancement features of symptomatic ICAD plaques under intensive medical therapy.
The investigators aim to explore the correlation between vulnerable plaque stratification and clinical outcomes, to explore the value of vascular responses in the pathogenicity of ICAD vulnerable plaques, as well as to provide objective basis for the establishment of the evaluation criteria of intracranial atherosclerotic vulnerable plaques.
Detailed description
Detailed description:
Title: Vessel wall and Perfusion Imaging in Intracranial Atherosclerosis
Design: This is an prospective study that will study the characteristics of intracranial atherosclerotic plaque and the enhancement features of symptomatic ICAD during a mean follow-up of 1 year in symptomatic or asymtomatic patients with moderate to severe stenosis of middle cerebral artery(MCA).
In the WASID trail,patients with at least 70% stenosis of a major intracranial artery had an increased risk of recurrent stroke. However,The degree of stenosis is no longer the single predictor of vulnerable atherosclerotic lesions. Vulnerable plaques are closely associated with stroke recurrence.With the development of neurologic imaging, HR-MRI has unique ability to provide information on plaque compositions, plaque burden and vulnerable features. Several recent investigations suggest that enhancement of intracranial plaque is associated with recurrent stroke. However, no corhort study has been performed.
This prospective, multicenter trail will be conducted in China. Based on the previous work,participants will be divided into two groups :symtomatic ICAD and asymtomatic ICAD. Neurological examination and clinical sera testing will be performed at baseline, 1 month, 3 months, 6 months, and 12 months.The stroke incidence rate of asymptomatic ICAD and stroke recurrence rate of symptomatic ICAD will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptomatic ICAD | – | –symptomatic intracranial atherosclerosis diseases |
| asymptomatic ICAD | – | –asymptomatic intracranial atherosclerosis diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with significant MCA stenosis（≥50%）on TCD, MRA, and/or CTA together with one or more risk factors of atherosclerosis will be prospectively recruited. Symtomatic patients will be included if they had suffered from a recent transient ischemic attack or ischemic stroke(NHISS≤6) in the territory of the stenotic MCA. Asymptomatic patients will be included if they had no history of cerebrovascular events or a history of an ischemic event in a territory outside that the affected MCA.
Key inclusion criteria (7 listed)
- Symptomatic patients who suffered TIA or non-severe ischemic stroke(NHISS ≤6) in one week with 50% to 90% stenosis of MCA.
- Asymptomatic patients with ≥50% MCA stenosis without history of cerebrovascular events or an ischemic event in a territory outside that supplied by the affected MCA.
- Degree of ≥50% stenosis must be conformed by MRA, CTA and/or TCD.
- Age: 18-80 years.
- mRS scale score of ≤2.
Key exclusion criteria (4 listed)
- Coexistent ipsilateral internal carotid stenosis（≥50%）on MRA, CTA and/or TCD. Non-atherosclerotic vasculopathy, such as dissection, vasculitis,or moyamoya disease.
- Evidence of cardioembolism, such as atrial fibrillation, mechanical prosthetic valve disease, sick sinus syndrome, dilated cardiomyopathy, left ventricular thrombus, or recent myocardial infarction, hemorrhage, watershed infarction, or other cerebral diseases, such as vascular malformation, neoplasms, and encephalopyosis.
- Patients who are unable to undergo HR-MRI owing to underlying medical conditions.
- Patients who are allergic to any of the study medications, including aspirin, clopidogrel,atorvastatin,or rosuvastatin.
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
Stroke recurrence
Time frame: 1 year
the number of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the stenotic MCA.
3 secondary outcomes
Death
Time frame: 1 year
Any stroke, severe transient ischemic attack (TIA) outside the territory of symptomatic MCA
Time frame: at 7 days, 30 days,3 months，6 months, 12 months
Stroke of asymptomatic participants
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Results publication: PubMed 25953365Mossa-Basha M, Hwang WD, De Havenon A, Hippe D, Balu N, Becker KJ, Tirschwell DT, Hatsukami T, Anzai Y, Yuan C. Multicontrast high-resolution vessel wall magnetic resonance imaging and its value in differentiating intracranial vasculopathic processes. Stroke. 2015 Jun;46(6):1567-73. doi: 10.1161/STROKEAHA.115.009037. Epub 2015 May 7.
- Results publication: PubMed 25628303Ahn SH, Lee J, Kim YJ, Kwon SU, Lee D, Jung SC, Kang DW, Kim JS. Isolated MCA disease in patients without significant atherosclerotic risk factors: a high-resolution magnetic resonance imaging study. Stroke. 2015 Mar;46(3):697-703. doi: 10.1161/STROKEAHA.114.008181. Epub 2015 Jan 27.
- Results publication: PubMed 24947295Ryoo S, Cha J, Kim SJ, Choi JW, Ki CS, Kim KH, Jeon P, Kim JS, Hong SC, Bang OY. High-resolution magnetic resonance wall imaging findings of Moyamoya disease. Stroke. 2014 Aug;45(8):2457-60. doi: 10.1161/STROKEAHA.114.004761. Epub 2014 Jun 19.
- Results publication: PubMed 24135208Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
- Results publication: PubMed 23828109Vakil P, Vranic J, Hurley MC, Bernstein RA, Korutz AW, Habib A, Shaibani A, Dehkordi FH, Carroll TJ, Ansari SA. T1 gadolinium enhancement of intracranial atherosclerotic plaques associated with symptomatic ischemic presentations. AJNR Am J Neuroradiol. 2013 Dec;34(12):2252-8. doi: 10.3174/ajnr.A3606. Epub 2013 Jul 4.
- Individual participant dataSharing planned: Yes. The date of individual participant will be recorded in case report form(CRF),which will be stored technically
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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.
Xiuhai Guo, MD contact
Qi Yang, MD contact
Guo Xiuhai, MD principal investigator
Xuanwu Hospital, Capital Medical University, Beijing, China
Qi Yang, MD principal investigator
Xuanwu Hospital, Capital Medical University, Beijing, China
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 Intracranial Atherosclerosis, run by Xiuhai Guo 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 7 inclusion and 4 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 4 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuhai Guo, MD (guoxhxuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke recurrence (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 NCT02719652, 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 Aug 2016.