ERILs Und SNILs Unter SOC | NCT05786170

Studies
ERILs Und SNILs Unter SOC

NCT05786170

Sponsor

Medical University of Vienna

Status

Withdrawn

Last Update Posted

Mar 27, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Stroke, Acute

Interventions

diffusion-weighted magnetic resonance imaging

Countries

Not provided

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of research funding

Expanded Access Info

Start Date

Sep 2019Estimated

Primary Completion Date

Jul 5, 2021Actual

Completion Date

Jul 5, 2021Actual

First Submitted Date

Mar 14, 2023

First Submission Date that Met QC Criteria

Mar 14, 2023

First Posted Date

Mar 27, 2023Actual

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

Mar 14, 2023

Last Update Posted Date

Mar 27, 2023Actual

Name	Class
Medical University Innsbruck	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?
How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment?
How many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?
Are there relevant risk faktors for the occurence of ERILs and SNILs (eg Diabetes or Biomarkers)?

Detailed Description

In this trial, patients will be observed if they develop early recurrent ischemic lesions (= ERILs) or silent neurologic ischemic lesions (= SNILs) after acute stroke or transitoric ischemic attack (TIA) based on atherothrombosis (LAA-stroke) on standard therapy during 30 days (day 7 and day 30 after acute event) via DW-MRI (diffusion-weighted magnetic resonance imaging).

We want to investigate if diffusion-weighted imaging of silent brain infarcts occuring during standard therapy is a suitable surrogate outcome measure for interventional studies

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
magnetic resonance imaging	Experimental	DW-MRI after ischemic stroke	Diagnostic Test: diffusion-weighted magnetic resonance imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diffusion-weighted magnetic resonance imaging	Diagnostic Test	diffusion-weighted magnetic resonance imaging	magnetic resonance imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?	DW-MRI to detect lesions	7 days after acute stroke

Secondary Outcomes

Measure	Description	Time Frame
2. How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment and how many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?	DW-MRI to detect lesions	30 days after acute stroke

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

LAA stroke or TIA
ERILs or SNILs detected in initialDW-MRI
signed informed consent

Exclusion Criteria:

planned surgical intervention
iv Thrombolysis
atrial fibrillation
contra indications against DW-MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D038524	Diffusion Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D008279	Magnetic Resonance Imaging
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided