Markers in the Diagnosis of TIA (MIND-TIA)
|ClinicalTrials.gov Identifier: NCT01954329|
Recruitment Status : Unknown
Verified June 2015 by F.H. Rutten, UMC Utrecht.
Recruitment status was: Recruiting
First Posted : October 1, 2013
Last Update Posted : June 15, 2015
MIND-TIA is primarily an observational diagnostic study that aims to evaluate the role of novel biomarkers in the diagnosis of Transient Ischemic Attack (TIA)in primary care.
Rapid and adequate diagnosis of TIA is of great importance to enable a rapid start of treatment, and thereby decrease the risk of subsequent ischemic stroke.
|Condition or disease|
|Transient Ischemic Attack|
A Transient Ischaemic Attack (TIA) does not cause permanent damage of brain tissue, but the risk of a subsequent ischemic stroke in the short term is high. Timely recognition of TIA would result in early treatment and reduce the risk of ischaemic stroke, and other adverse cardiovascular events.
To improve the management of TIA adequate diagnosis is of imminent importance. However the diagnosis is notoriously difficult, for both GP and neurologist.
Adequate biomarkers for brain ischaemia could improve the early diagnosis and thus the subsequent management of TIA.
To assess the added diagnostic value of biomarkers beyond the clinical assessment (medical history, signs and symptoms) in patients suspected of TIA.
- To assess the prognostic value of biomarkers in patients with an established diagnosis of TIA.
- To assess the time delay and factors related to delay in patients suspected of TIA.
350 adult persons suspected of TIA from primary care.
Recruitment of patients will be performed at the general practices of 200 GPs in the vicinity of 4 to 5 participating hospitals. During a home visit a research nurse collects a blood sample, and takes two health-related questionnaires. Participants will be referred by their GP to the regional TIA outpatient clinic for additional investigations, including brain imaging. The diagnostic accuracy of a set of biomarkers will be assessed with the 'definite' diagnosis of TIA by a panel of neurologists as the reference standard.
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Markers in the Diagnosis of TIA|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||March 2016|
|Patients suspected of TIA by the GP|
- 'Definite' Diagnosis of TIA [ Time Frame: After 6 months of follow-up ]Determined by expert panel consisting of 3 neurologists
- Ischemic stroke and other cardiovascular events [ Time Frame: During 6 months of follow-up ]Assessed in the medical records of the GPs
- Time delay to GP consultation and start of treatment [ Time Frame: 1 day of home visit ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954329
|Contact: Louis Servaas Dolmans, MD||+31-88-7568159||L.S.Dolmans@umcutrecht.nl|
|Julius Center UMC Utrecht||Recruiting|
|Utrecht, Netherlands, 3508 GA|
|Sub-Investigator: Faas LS Dolmans, MD|
|Principal Investigator: Frans H Rutten, MD, PhD|
|Sub-Investigator: Marie-Louise EL Bartelink, MD, PhD|
|Sub-Investigator: Jaap LJ Kappelle, MD, PhD|
|Sub-Investigator: Arno W Hoes, MD, PhD|