BIO-PREDISC-TIA SWISS Cohort Study | NCT03994003

Studies
BIO-PREDISC-TIA SWISS Cohort Study

NCT03994003

Sponsor

Dr. med. Carlo Cereda

Status

Completed

Last Update Posted

Apr 18, 2024Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Cerebrovascular Disease, Ischemic 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 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

Aug 4, 2017Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Jun 19, 2019

First Submission Date that Met QC Criteria

Jun 19, 2019

First Posted Date

Jun 21, 2019Actual

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 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Name	Class
Ente Ospedaliero Cantonale, Bellinzona	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

This research project aims at contributing to improve TIA diagnosis and management by using PREDISC scores and specific biomarkers thought to have elevated levels in TIA patients. A swift and accurate TIA diagnosis allows starting treatment of the patient adequately and shortly after the event. The shorter the time between the event and treatment onset, the better the outcome. This approach will be an important step forward in TIA diagnosis and management, similarly to acute coronary syndrome as discussed above.

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

64Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levels of specific biomarkers (Platelet Basic Protein (PBP), ceruloplasmin, microRNAs, exosomal particles) in patients with suspected TIA.	Diagnostic performance according to PREDISC scale	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting <24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.
- At least 18 years old.
- Having given their Informed Consent.

Exclusion Criteria:

· Patients with ocular TIA (Amaurosis fugax).
- Patients that still have neurological deficits at the moment of inclusion.
- Contraindication to perform MRI.
- For women: pregnancy.

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

Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting <24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlo Cereda, MD	Neurocentro della Svizzera Italiana Ospedale Regionale di Lugano	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier Vaudois		Lausanne	Canton of Vaud	1011	Switzerland
Ospedale Regionale di Lugano

Condition Browse Module

MeSH Terms

ID	Term
D002561	Cerebrovascular Disorders
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

MiRNA will be isolated from whole blood collected in PAXgene tubes (BD/PreAnalytiX, Franklin Lakes, NJ). PAXgene tubes contain an RNA stabilizing reagent that acts at time of blood draw to prevent RNA degradation. RNA in whole blood is derived mainly from peripheral blood cells (monocytes, neutrophils, T cells, B cells, and megakaryocytes).