The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute StrokeNCT06289036
Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging
An observational study of The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| favorable prognosis | modified Rankin scale (mRS) ≤ 2 | |
| poor prognosis | modified Rankin scale (mRS) > 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale（mRS） score after 3 months of onset
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Feb 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyuan Shen, The First Hospital of Hebei Medical University
- Investigators
- Shujuan Tian, MD, Principal investigator, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289036
- Sponsor's protocol ID
- H2020206632
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Prognosis in Subacute Ischemic Stroke Through Brain Perfusion and Collateral Circulation With Multimodal Imaging
- ClinicalTrials.gov ID
- NCT06289036
- Acronym / sponsor ID
- H2020206632
- Conditions
- The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| favorable prognosis | – | –modified Rankin scale (mRS) ≤ 2 |
| poor prognosis | – | –modified Rankin scale (mRS) > 2 |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shujuan Tian, MD principal investigator
The First Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale（mRS） score after 3 months of onset (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.