NCT03994003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

3.4 years

First QC Date

June 19, 2019

Last Update Submit

April 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • · Patients with ocular TIA (Amaurosis fugax).
  • Contraindication to perform MRI.
  • For women: pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre hospitalier Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, Canton Ticino, 6900, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

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).

MeSH Terms

Conditions

Cerebrovascular DisordersIschemic Stroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStroke

Study Officials

  • Carlo Cereda, MD

    Neurocentro della Svizzera Italiana Ospedale Regionale di Lugano

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD Capo Servizio

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 21, 2019

Study Start

August 4, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations