- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06289036
Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging
February 24, 2024 updated by: Zhiyuan Shen, The First Hospital of Hebei Medical University
Predicting Prognosis in Subacute Ischemic Stroke Through Brain Perfusion and Collateral Circulation With Multimodal Imaging
We enrolled patients with subacute IS, associated with moderate-to-severe stenosis of the unilateral cervical internal carotid artery, who underwent 4D ASL.
Perfusion levels and collateral circulation were compared between groups with favorable prognosis (modified Rankin scale [mRS] ≤ 2) and poor prognosis (mRS > 2).
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
-
Shijia Zhuang, Hebei, China
- The First Hospital of Hebei Medical University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients with moderate-to-severe stenosis/occlusion of the MCA or carotid artery admitted to the First Hospital of Hebei Medical University between July 2022 and October 2023.
Description
Inclusion Criteria:
- Confirmed unilateral internal carotid artery/MCA atherosclerotic stenosis/occlusion with a stenosis degree > 50% verified through computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
- Presence of IS or transient ischemic attack (TIA) symptoms in the circulating blood supply area within the preceding 48 h.
- Asymptomatic patients with no history of IS or TIA in the past 6 months.
- Performance of 4D ASL tests during hospitalization.
Exclusion Criteria:
- Moderate-to-severe stenosis/occlusion of the contralateral internal carotid artery/middle cerebral arteries.
- Age ≤ 18 years old.
- Cardioembolic cerebral infarction.
- Moyamoya disease.
- Combined or previous cerebral hemorrhage or subarachnoid hemorrhage
- History of previous cerebral infarction.
- Claustrophobia or the presence of intracranial metal implants, cochlear implants, or pacemakers.
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
Cohorts and Interventions
Group / Cohort |
|---|
|
favorable prognosis
modified Rankin scale (mRS) ≤ 2
|
|
poor prognosis
modified Rankin scale (mRS) > 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Rankin Scale(mRS) score after 3 months of onset
Time Frame: 3 months
|
mRS scores range from 0 to 6, where 0 indicates no symptoms, 3 indicates moderate disability, 4 indicates moderately severe disability, 5 indicates severe disability, and 6 indicates death.
Patients were categorized into a good prognosis group (mRS ≤ 2) and a poor prognosis group (mRS > 2).
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shujuan Tian, MD, The First Hospital of Hebei Medical University
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 (Actual)
February 1, 2021
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
February 24, 2024
First Submitted That Met QC Criteria
February 24, 2024
First Posted (Actual)
March 1, 2024
Study Record Updates
Last Update Posted (Actual)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 24, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2020206632
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.