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Stroke Mechanism Evolution in Intracranial Atherosclerotic Stenosis

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ClinicalTrials.gov Identifier: NCT02705599
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Xin Lou, Chinese PLA General Hospital

Brief Summary:
Predictors of the risk of recurrent stroke for patients with symptomatic intracranial atherosclerotic stenosis (ICAS) remain unknown. The study will be to explore the stroke mechanism evolution in patients with ICAS by multi-model magnetic resonance imaging (MRI) which consists of diffusion-weighted imaging (DWI) and high-resolution MRI (HRMRI). The patients with symptomatic ICAS will undergo multi-model MRI. The baseline data, infarct patterns on DWI, and plaque features on HRMRI will be collected. The stroke mechanisms will be determined by the infarct patterns. During the 2 years follow-up, the recurrent ischemic events will be recorded. By comparing the baseline data, infarct patterns, and plaque features in patients with and without recurrent strokes, the high-risk features of patients with symptomatic ICAS will be identified. The evaluation of stroke mechanisms of patients with symptomatic ICAS will be summarized.

Condition or disease
Stroke

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stroke Mechanism Evolution in Intracranial Atherosclerotic Stenosis
Actual Study Start Date : August 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Ischemic stroke event (in the stenotic vascular territory) [ Time Frame: To 2 years ]
    The primary outcome will include ischemic stroke (in the stenotic vascular territory) and vascular death.


Secondary Outcome Measures :
  1. Ischemic stroke event (in the non-stenotic vascular territory) [ Time Frame: To 2 years ]
    The second outcome will include ischemic stroke (in the non-stenotic vascular territory) , transient ischemic attack, brain hemorrhage, and all-cause death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Symtomatic patients with intracranial atherosclerostic stenosis
Criteria

Patients suspected of having symptomatic ICAD at admission will be enrolled. All patients will receive a thorough evaluation to determine the cause of their ischemic event (TIA or ischemic stroke), including carotid duplex, transcranial Doppler, echocardiography, electrocardiogram, computed tomography (CT), CT angiography, MRI, magnetic resonance angiography (MRA), or digital subtraction angiography DSA.

Patients will be enrolled in this study according to if they met the following:

  • ischemic stroke or TIA in the target territories of the intracranial anterior or posterior circulation within 90 days;
  • Lack of coexistent≥50% ipsilateral extracranial carotid artery or vertebral artery stenosis;
  • No potential sources of cardio-aortic embolism based on the modified Trial of ORG 10172 in Acute Stroke Treatment classification;
  • Age ≥18 years;
  • One or more atherosclerotic risk factors including hypertension, hypercholesterolemia, diabetes mellitus, cigarette smoking, and obesity.

Exclusion Criteria:

  • Non-atherosclerosis vasculopathy such as vasculitis and arterial dissection diagnosed by comprehensive laboratory work (such as erythrocyte sedimentation rate or C-reactive protein elevations, antinuclear antibody, or antiphospholipid antibody positivity), vascular imaging, and clinical evaluation;
  • Contraindication to MR examination, medical instability precluding MR examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705599


Contacts
Contact: Jinhao Lyu +86 13391851857 lvjinhao@hotmail.com
Contact: Ning Ma, M.D. Ph.D. +86 13581889908 maning_03@hotmail.com

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jinhao Lyu, BS    +8613391851857    lvjinhao@hotmail.com   
China
Beijing Tiantan Hospital Recruiting
Beijing, China, 100853
Contact: Ning Ma, M.D. Ph.D         
Sponsors and Collaborators
Chinese PLA General Hospital
Beijing Tiantan Hospital
Investigators
Principal Investigator: Xin Lou, M.D. Ph.D. Chinese PLA General Hospital
Principal Investigator: Ning Ma, M.D. Ph.D. Beijing Tiantan Hospital

Publications:
Responsible Party: Xin Lou, Deputy Chief, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02705599     History of Changes
Other Study ID Numbers: HRMRI-NM-Tiantan
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xin Lou, Chinese PLA General Hospital:
Ischemic stroke
High resolution MRI
Perfusion
Mechanism

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases