Cell-free DNA in Acute Stroke | NCT06928675

Studies
Cell-free DNA in Acute Stroke

NCT06928675

Sponsor

University Hospital, Basel, Switzerland

Status

Recruiting

Last Update Posted

Apr 15, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Switzerland

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2025Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Mar 18, 2025

First Submission Date that Met QC Criteria

Apr 7, 2025

First Posted Date

Apr 15, 2025Actual

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

Apr 7, 2025

Last Update Posted Date

Apr 15, 2025Actual

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

Cell-free DNA (cfDNA) is an important pro-inflammatory and prothrombotic mediator. With this study the investigators aim to gain new insights into the role of cfDNA in stroke and to perform a combined analysis of cfDNA in the hyperacute phase of the disease using blood and thrombus analyses. The main objectives are to analyse cfDNA in different stroke etiologies, to investigate the relationship between cfDNA and important procedural factors such as secondary embolisation and reperfusion outcomes, to analyse the correlation between blood and thrombus content of cfDNA and to investigate the specific source of cfDNA in distinct stroke subtypes.

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

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroke Etiology	Descriptive comparison of cell-free DNA in cerebral thrombi regarding stroke etiology	at day 1

Secondary Outcomes

Measure	Description	Time Frame
Correlation cfDNA concentration and perfusion outcome	cfDNA abount in blood and thromi is assessed in relation to thrombectomy outcomes including perfusion outcome	at day 1
Correlation cfDNA concentration and secondary embolism

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute ischemic stroke due to large vessel occlusion (LVO) who require mechanical thrombectomy (detected in CT-Scan or MRI-Scan)
18 years of age

Exclusion Criteria:

Patients currently undergoing immunological therapies.
Patients with immunological diseases
Patients with systemic infections at the time of admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

male or female patients over 18 years of age presenting with acute ischemic stroke due to large vessel occlusion (LVO) who require mechanical thrombectomy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gerrit Grosse, PD Dr. Dr.	Contact	+41 61 32 85265		gerrit.grosse@usb.ch

Overall Officials

Name	Affiliation	Role
Gerrit Grosse, PD Dr. Dr.	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel	Recruiting	Basel		4031	Switzerland

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