BIO-PREDISC-TIA SWISS Cohort Study (PREDISC)

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: Cerebrovascular Disease, Ischemic Stroke

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

• Study Contact: Name: Carlo Cereda, MD; Phone Number: +41918116691; Email: Carlo.Cereda@eoc.ch
• Study Contact Backup: Name: Concetta Manno, MD; Phone Number: +418116454; Email: Concetta.Manno@eoc.ch

Study Locations

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

Participation Criteria

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

How is the study designed?

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.	Diagnostic performance according to PREDISC scale	1 year

Collaborators and Investigators

• 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

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: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Cerebrovascular Disorders
• 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