BIO-PREDISC-TIA SWISS Cohort Study (PREDISC)

April 16, 2024 updated by: Dr. med. Carlo Cereda

BIOmarkers and PREDISC Diagnostic Evaluation for Patients With Suspected Transient Ischemic Attacks: the BIOPREDISC- TIA SWISS Cohort Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Ospedale Regionale di Lugano
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Centre hospitalier Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. med. Carlo Cereda

Collaborators

Ente Ospedaliero Cantonale, Bellinzona

Investigators

  • Study Director: Carlo Cereda, MD, Neurocentro della Svizzera Italiana Ospedale Regionale di Lugano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC.NSISU.4.12.99

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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