Application CT and MRI in Cerebral Venous Sinus Thrombosis | NCT04966182

Studies
Application CT and MRI in Cerebral Venous Sinus Thrombosis

NCT04966182

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jul 19, 2021Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Magnetic Resonance Imaging
Cerebral Venous Sinus Thrombosis
Computer Tomographgy

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Jul 11, 2021

First Submission Date that Met QC Criteria

Jul 11, 2021

First Posted Date

Jul 19, 2021Actual

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

Jul 11, 2021

Last Update Posted Date

Jul 19, 2021Actual

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

Cerebral venous thrombosis (CVT) is a rare disease, and with poor prognosis. Computed tomography (CT) andmagnetic resonance imaging (MRI) are the most commonly used image modalities for patients with non-specific neurologic symptoms. We are going to assess the accuracy of CT and MRI in the differential diagnosis of CVT and cerebral venous sinus thrombosis (CVST).

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

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
specificity and sensitivity of CT	specificity and sensitivity of CT in the diagnosis of cerebral venous sinus thrombosis	2022.01
specificity and sensitivity of MRI	specificity and sensitivity of MRI in the diagnosis of cerebral venous sinus thrombosis	2022.01

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A. The patients were diagnosed with cerebral venous thrombosis or cerebral venous sinus thrombosis; B. The patients completed at least cranial CT or MRI examination upon admission;C. The patients complete at least one of the CTV, MRV or DSA examination.

Exclusion Criteria:

A. Patients with severe cardiopulmonary insufficiency;B. Patients lost to follow-up;C. Patients with incomplete access to imaging data;D. Patients with cerebral venous sinus thrombosis that was not diagnosed at discharge.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All the patients with the diagnosis of cerebral venous thrombosis or cerebral venous sinus thrombosis at admission were included.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xu weilin, Ph.D	Contact	+8618758140251	310000	11618330@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310009	China