Vessel Wall and Perfusion Imaging in Intracranial Atherosclerosis

August 3, 2016 updated by: Xiuhai Guo

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
symptomatic ICAD
symptomatic intracranial atherosclerosis diseases
asymptomatic ICAD
asymptomatic intracranial atherosclerosis diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 1 year
The number of participants who suffer from death after enrollment
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
The number of participants who suffer from 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
Time Frame: 1 year
The number of asymptomatic participants who suffer from stroke after enrollment in the territory of the stenotic MCA；
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiuhai Guo

Investigators

  • Principal Investigator: Guo Xiuhai, MD, Xuanwu hospital, capital medical university, Beijing, China
  • Principal Investigator: Qi Yang, MD, Xuanwu hospital, capital medical university, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICAD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The date of individual participant will be recorded in case report form(CRF),which will be stored technically

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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