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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02274727
Other study ID # 2014-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2014
Est. completion date December 2021

Study information

Verified date November 2021
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The three-year cumulative risk of a recurrent stroke, dependent on aetiology, is up to 25 per cent. At present, preventing recurrence relies on a broad approach to reduce risk factors associated with atherosclerosis, heart disease and metabolic disorders. However, more specific interventions, such as anticoagulation and surgery or stenting, need aetiologic information. BIOSIGNAL aims to determine where the most promising candidate biomarkers can help identify stroke aetiology and also predict overall MACE, including specifically recurrent stroke. In addition, the insights gained into the processes underlying different stroke subtypes may lead to more targeted diagnostic tools.


Description:

Objectives and specific aims: The investigators propose to prospectively evaluate the predictive value of the most promising blood bio-markers to identify treatable stroke etiologies on admission and risk of MACE and its components in consecutive ischemic stroke patients enrolled by several centers in Europe. The clinical endpoints of the study are 1) recurrent cerebrovascular events (ischemic stroke and / or transient ischemic attack (TIA)) and major cardiac events (MACE) within one year after the index stroke and after 3-5 years of follow up (2021) 2) all types of atrial fibrillation (AF) detected on admission or by prolonged ambulatory cardiac rhythm monitors during the follow up period 3) presence of cerebrovascular atherosclerosis detected by ultrasound investigations and 4) overall mortality, functional outcome, cognitive impairment, occurrence of epilepsy, and newly diagnosed cancer, according to data collected in telephonic interviews in 2021 (only in Zurich and Basel) with the patients enrolled between 2014-2017. Aim 1: To determine whether the proposed and novel biomarkers independently predict recurrent stroke and a composite outcome consisting of recurrent cerebrovascular event (ischemic stroke (AIS), intracranial hemorrhage (ICH) or transient ischemic attack (TIA), as well as myocardial infarction (MI), cardiovascular death (CVD)). i.e. major adverse cardiac events (MACE) among all patients. Hypothesis 1: Elevated levels of one or more of the proposed and novel biomarkers will independently predict MACE and its components during trial follow-up, assessed by structured interviews, as well as chart reviews 90 days, 1 year after the index stroke as well as in 2021 (only in Zurich and Basel). Aim 2: To determine whether CE biomarkers are associated with atrial fibrillation among all patients. Hypothesis 2: Baseline values of one or more of the CE biomarkers will be independently associated with AF, including history of AF, AF detection at baseline, or AF detected during the follow up period by prolonged (at least 7-day) ambulatory cardiac rhythm monitors and structured interviews as well as chart reviews 90 days, 1 year after the index stroke as well as in 2021 (only in Zurich and Basel). Aim 3: To determine whether LAA biomarkers are associated with a) the presence of cerebrovascular atherosclerosis among all patients. Hypothesis 3: Baseline values of one or more of LAA biomarkers will be independently associated with the presence of extra and intracranial atherosclerosis among patients with ischemic stroke. Exploratory Aim 4: To determine whether the proposed and novel biomarkers will predict a) occurrence of epileptic seizures and diagnosis of epilepsy b) newly diagnosed cancer, c) functional outcome and cognitive impairment. Hypothesis 4: Baseline values of one or more of the proposed and potentially novel biomarkers will independently predict a) occurrence of epileptic seizures and the diagnosis of epilepsy b)occurrence of newly diagnosed cancer c) functional outcome and cognitive impairment assessed by a follow up structured telephone interview performed in 2021 with the patients enrolled between 2014-2017 (only in Zurich and Basel). This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, and Good Clinical Practice (GCP) guidelines as well as all national legal and regulatory requirements.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1800
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All consecutive patients (above the age of 18) who are admitted with a suspected ischemic stroke within 24 hours of symptom onset are eligible. Ischemic stroke is defined as an acute localized ischemic lesion in the brain not attributable to central nervous system infection, tumor, demyelinating, or degenerative neurologic diseases due to an occlusive vascular disorder. Detailed Inclusion Criteria: 1. Rapid onset of a focal neurologic deficit, with signs or symptoms persisting beyond 24 hours & NOT associated with: - infection - trauma - tumor of the brain - severe metabolic disorders - chronic degenerative neurologic disease 2. The development of an acute focal neurologic deficit persisting >24 hours in conjunction with brain imaging consistent with acute ischemic stroke. The CT or MRI may either show a new infarct or no change from the study performed at entry, i.e. the diagnosis is clinical and does not require CT/MRI confirmation. Secondary hemorrhagic infarction is permissible. Exclusion Criteria: 1. Hemorrhagic stroke 2. All patients discharged from the hospital with a diagnosis different from ischemic stroke (i.e. stroke mimics)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital of Frankfurt Frankfurt am Main
Greece Larissa University Hospital of Thessaly Larissa
Spain Universitiy Hospital Vall d'Hebron Barcelona
Switzerland Kantonsspital Aarau, Department of Neurology Aarau Argau
Switzerland University Hospital of Basel Basel
Switzerland University Hospital of Bern/Inselspital Bern
Switzerland Stroke Center ; Neurocentro(EOC) della Svizzera Italiana Lugano
Switzerland Stroke Center, Kantonsspital St.Gallen St.Gallen
Switzerland University Hospital of Zurich, Department of Neurology Zurich

Sponsors (2)

Lead Sponsor Collaborator
University of Zurich Swiss National Science Foundation

Countries where clinical trial is conducted

Germany,  Greece,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Functional outcome Assessed by the modified Rankin scale (mRS) Within 3 month after the index stroke and at one year. In Zurich and Basel also in 2021
Other Occurrence of epileptic seizures and the diagnosis of epilepsy According to the medical history reported by patient and a questionnaire During 2021 (only in Zurich and Basel)
Other Ooccurrence of newly diagnosed cancer According to the medical history reported by patient During 2021 (only in Zurich and Basel)
Other Cognitive impairment Assessed by the Telephone Interview for Cognitive Status (TICS) Questionnaire During 2021 (only in Zurich and Basel)
Other Mortality All-cause death Within 1 year after the index event. In Zurich and Basel also in 2021
Primary Composite of Major adverse cardiac events (MACE) Recurrent cerebrovascular events (ischemic stroke (AIS), intracranial hemorrhage (ICH) or transient ischemic attack (TIA)), as well as myocardial infarction (MI), cardiovascular death (CVD). i.e. major adverse cardiac events (MACE) Within 1 year after the index event. In Zurich and Basel also in 2021
Secondary Single components and combinations of MACE Recurrent cerebrovascular events (ischemic stroke (AIS), intracranial hemorrhage (ICH) or transient ischemic attack (TIA)), myocardial infarction (MI) or cardiovascular death (CVD) Within one year after the index stroke
Secondary Stroke aetiology According to TOAST and SS TOAST criteria During first hospitalisation (cross-sectional analysis, up to 14 days)
Secondary History of AF Assessed by chart review and taking the patients history Diagnosed befor the stroke
Secondary Newly Atrial Fibrillation (AF) Newly diagnosed atrial fibrillation in patients with no history of AF On admission and during a one year of follow-up by PCM. In Zurich and Basel also in 2021
Secondary The presence of cerebrovascular atherosclerosis among all patients. Assessed by duplex sonography. During first hospitalisation (cross-sectional analysis, up to 14 days)
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