Vessel Wall and Perfusion Imaging in Intracranial Atherosclerosis

NCT ID: NCT02719652

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-09-30

Brief 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. 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:

1. plaque characteristics and the enhancement features between symptomatic ICAD and asymptomatic ICAD

2. the relationship between plaque enhancement and the composition of plaques;

3. relationship among enhancement features of symptomatic ICAD plaques, biomarkers with different clinical significance,

4. 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.

Conditions

Intracranial Atherosclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

symptomatic ICAD

symptomatic intracranial atherosclerosis diseases

No interventions assigned to this group

asymptomatic ICAD

asymptomatic intracranial atherosclerosis diseases

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiuhai Guo

OTHER

Sponsor Role: lead

Responsible Party

Xiuhai Guo

Director of Clinical Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guo Xiuhai, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Capital Medical University, Beijing, China

Qi Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Capital Medical University, Beijing, China

Locations

Department of Neurology, Xuanwu hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuhai Guo, MD

Role: CONTACT

guoxhxuan@126.com

Qi Yang, MD

Role: CONTACT

yangyangqiqi@gmail.com

Facility Contacts

Xiuhai Guo, MD

Role: primary

guoxhxuan@126.com

Qi Yang, MD

Role: backup

yangyangqiqi@gmail.com

86-18910766178

References

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.

Reference Type: RESULT

PMID: 25953365 (View on PubMed)

Ahn 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.

Reference Type: RESULT

PMID: 25628303 (View on PubMed)

Ryoo 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.

Reference Type: RESULT

PMID: 24947295 (View on PubMed)

Holmstedt 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.

Reference Type: RESULT

PMID: 24135208 (View on PubMed)

Vakil 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.

Reference Type: RESULT

PMID: 23828109 (View on PubMed)

Other Identifiers

ICAD-001

Identifier Type: -

Identifier Source: org_study_id