Prognosis in Subacute Ischemic Stroke Using Multimodal Im... | NCT06289036

Studies
Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging

NCT06289036

Sponsor

The First Hospital of Hebei Medical University

Status

Completed

Last Update Posted

Mar 1, 2024Actual

Enrollment

28Actual

Phase

Not provided

Conditions

The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Feb 24, 2024

First Submission Date that Met QC Criteria

Feb 24, 2024

First Posted Date

Mar 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2024

Last Update Posted Date

Mar 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
favorable prognosis		modified Rankin scale (mRS) ≤ 2
poor prognosis		modified Rankin scale (mRS) > 2

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

88 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shujuan Tian, MD	The First Hospital of Hebei Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Hospital of Hebei Medical University		Shijiazhuang	Hebei		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided