UnknownNot Applicable

Vessel Wall and Perfusion Imaging in Intracranial Atherosclerosis

China300 participantsStarted 2015-11

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stroke recurrence

Timeframe: 1 year

Trial details

NCT IDNCT02719652

SponsorXiuhai Guo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-06

Contact for this trial

Xiuhai Guo, MD

guoxhxuan@126.com

View on ClinicalTrials.gov More Intracranial Atherosclerosis trials