High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorGeneral Hospital of Shenyang Military Region
About this trial
Intracranial atherosclerotic disease is the most common cause of ischemic stroke in Asia, also in China. Currently, despite vascular recanalization therapy, statins are one of the main drug choices for treating atherosclerotic plaque. High resolution magnetic resonance imaging (HRMRI) can accurately assess the status of intracranial and extracranial arterial plaque, and has high consistency with histopathology. Thus, HRMRI technology has been widely used to monitor the efficacy of drug treatment for atherosclerotic plaque in clinical trials or practice.
As a non-invasive technique, HRMRI make it possible to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery in vivo. It can quantitative analysis including components such as lipid-rich necrotic core, fiber cap thickness, intra-plaque hemorrhage, calcification, etc. Therefore, it is crucial for evaluating the etiology of ischemic stroke and developing secondary prevention strategies.
At present, there is a lack of large-scale and prospective study to evaluate the etiology of ischemic stroke including cryptogenic stroke based on HRMRI. In this context, this study aims to establish a multi center HRMRI database of intracranial arteries among Chinese patients with ischemic stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Patient age ≥40 years
2. Time of stroke onset: within 2 week
3. Baseline NIHSS score ≤16
4. Ischemic stroke confirmed by head CT or MRI
Disqualifiers
1. Intracranial hemorrhage found by head CT
2. Had a contraindication to MRI,or could not complete required MRI sequences
3. Intracranial tumor, arteriovenous malformation, or aneurysm
4. Comorbidity with any serious diseases and life expectancy is less than one year
Trial population
patients with ischemic stroke who performed HRMRI
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Registration
Other interventioncollect clinical date, assess the morphologic characteristics of plaque
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Recurrence of stroke
including ischemic or hemorrhagic stroke
Time frame
360 daysSecondary outcomes
1
Recurrence of stroke
including ischemic or hemorrhagic stroke
Time frame
90 days, 180 days2
the composite events of cardiovascular events
Cardiovascular events include cardiovascular death, stroke, non-fatal myocardial infarction, and arterial revascularization
Time frame
90 days, 180 days, 360 days3
distribution of modified Rankin Scale (mRS) score
mRS score range from 0 to 6: 0 \[no symptoms\] to 6 \[death\]
Time frame
90 days, 180 days 360 days4
The relationship between characteristics of intracranial plaques and functional independence
characteristics of intracranial plaques includes plaque composition, location and morphology; functional independence is defined as modified Rankin Scale (mRS) score 0-1 (mRS score range from 0 to 6: 0 \[no symptoms\] to 6 \[death\])
Time frame
90 days, 180 days, 360 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov