Vessel Wall and Perfusion Imaging in Intracranial Atherosclerosis

NCT02719652 | Unknown DMC

• 1 other identifier: ICAD-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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. 1.plaque characteristics and the enhancement features between symptomatic ICAD and asymptomatic ICAD
2. 2.the relationship between plaque enhancement and the composition of plaques;
3. 3.relationship among enhancement features of symptomatic ICAD plaques, biomarkers with different clinical significance,
4. 4.evolution of enhancement features of symptomatic ICAD plaques under intensive medical therapy.

Conditions

Intracranial Atherosclerosis

Keywords

intracranial atherosclerotic disease（ICAD）; vulnerable plaque; high-resolution magnetic resonance imaging （HR-MRI）

Outcome Measures

Primary Outcomes (1)

• Stroke recurrence

  the number of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the stenotic MCA.

  1 year

Secondary Outcomes (3)

• Death

  1 year

• Any stroke, severe transient ischemic attack (TIA) outside the territory of symptomatic MCA

  at 7 days, 30 days,3 months，6 months, 12 months

• Stroke of asymptomatic participants

  1 year

Study Arms (2)

symptomatic ICAD

symptomatic intracranial atherosclerosis diseases

asymptomatic ICAD

asymptomatic intracranial atherosclerosis diseases

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiuhai Guo: lead

Study Sites (1)

Department of Neurology, Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 25953365 RESULT

• 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.

  PMID: 25628303 RESULT

• 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.

  PMID: 24947295 RESULT

• 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.

  PMID: 24135208 RESULT

• 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.

  PMID: 23828109 RESULT

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guo Xiuhai, MD

  Xuanwu Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

• Qi Yang, MD

  Xuanwu Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuhai Guo, MD

CONTACT

guoxhxuan@126.com

Qi Yang, MD

CONTACT

yangyangqiqi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 25, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2017
• Last Updated: August 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)