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BIO-PREDISC-TIA SWISS Cohort Study (PREDISC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994003
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. med. Carlo Cereda, Ospedale Civico, Lugano

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.

Condition or disease
Cerebrovascular Disease, Ischemic Stroke

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BIOmarkers and PREDISC Diagnostic Evaluation for Patients With Suspected Transient Ischemic Attacks: the BIOPREDISC- TIA SWISS Cohort Study
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021



Primary Outcome Measures :
  1. 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


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).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994003


Contacts
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Contact: Carlo Cereda, MD +41918116691 Carlo.Cereda@eoc.ch
Contact: Concetta Manno, MD +418116454 Concetta.Manno@eoc.ch

Locations
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Switzerland
Ospedale Regionale di Lugano Recruiting
Lugano, Ticino, Switzerland, 6900
Contact: Carlo W Cereda, MD Ph    +41918116691    carlo.cereda@eoc.ch   
Contact: Jane M Frangi, RN    +41918116050    janemarit.frangi-kultalahti@eoc.ch   
Sub-Investigator: Giovanni Bianco, MD         
Centre hospitalier Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Patrik Michel, Prof.    +41213141185    patrik.michel@chuv.ch   
Contact: Ashraf Eskandari    +41213141265    ashraf.eskandari@chuv.ch   
Sponsors and Collaborators
Dr. med. Carlo Cereda
Investigators
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Study Director: Carlo Cereda, MD Neurocentro della Svizzera Italiana Ospedale Regionale di Lugano
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Responsible Party: Dr. med. Carlo Cereda, MD Capo Servizio, Ospedale Civico, Lugano
ClinicalTrials.gov Identifier: NCT03994003    
Other Study ID Numbers: EOC.NSISU.4.12.99
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Ischemia
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases