Biomarker Signature of Stroke Aetiology Study: The BIOSIGNAL-Study

Active, not recruiting

Phase Results N/A

Update History

4 May '18
The Summary of Purpose was updated.
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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 biomarkers can help identify stroke aetiology and also predict recurrent stroke. In addition, the insights gained into the processes underlying different stroke subtypes may lead to more targeted diagnostic tools.
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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 biomarkers can help identify stroke aetiology and also predict recurrent stroke. In addition, the insights gained into the processes underlying different stroke subtypes may lead to more targeted diagnostic tools.
The description was updated.
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Objectives and specific aims: The investigators propose to prospectively evaluate the predictive value of the most promising blood biomarkers to identify treatable stroke etiologies on admission and risk of recurrence in 3000 consecutive ischemic stroke patients enrolled by 10 centers in Europe and the US. The clinical endpoints of the study are 1) recurrent stroke within one year, 2) all types of atrial fibrillation (AF) detected on admission or by prolonged ambulatory cardiac rhythm monitors, 3) presence of cerebrovascular atherosclerosis detected by ultrasound investigations and 4) new silent ischemic brain lesions and progression of chronic cerebral ischemic lesion volume detected by repeated magnetic resonance imaging (MRI and MRA) and (i.e. on admission and after 12 months). Aim 1: To determine whether the proposed biomarkers independently predict recurrent stroke among all patients. Hypothesis 1: Elevated levels of one or more of the proposed biomarkers will independently predict recurrent strokes during trial follow-up, assessed by structured interviews, as well as chart reviews 90 days and 1 year after the index stroke. Aim 2: To determine whether cardioembolic (CE) biomarkers are associated with atrial fibrillation among all patients. Hypothesis 2: Baseline values of one or more of the proposed 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 ambulatory cardiac rhythm monitors and structured interviews as well as chart reviews 90 days and 1 year after the index stroke. Aim 3: To determine whether large artery atherosclerosis (LAA) biomarkers are associated with a) the presence of cerebrovascular atherosclerosis among all patients. Hypothesis 3: Baseline values of one or more of the proposed LAA biomarkers will be independently associated with the presence of extra and intracranial atherosclerosis among patients with ischemic stroke, assessed by duplex sonography. Exploratory Aim 4: To determine whether the proposed biomarkers will predict b) new silent strokes and c) progression of chronic cerebral ischemic lesion (white matter hyper-intensity) volume (WMHV) among cryptogenic stroke patients. Hypothesis 4: Baseline values of one or more of the proposed biomarkers will independently predict a) silent stroke b) progression of WMHV, during study follow-up, assessed by repeated magnetic resonance imaging (MRI) (on admission, and 1 year after the index stroke). 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.
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Objectives and specific aims: The investigators propose to prospectively evaluate the predictive value of the most promising blood biomarkers to identify treatable stroke etiologies on admission and risk of recurrence in 3000 consecutive ischemic stroke patients enrolled by 10 centers in Europe and the US. The clinical endpoints of the study are 1) recurrent stroke within one year, 2) all types of atrial fibrillation (AF) detected on admission or by prolonged ambulatory cardiac rhythm monitors, 3) presence of cerebrovascular atherosclerosis detected by ultrasound investigations and 4) new silent ischemic brain lesions and progression of chronic cerebral ischemic lesion volume detected by repeated magnetic resonance imaging (MRI and MRA) and (i.e. on admission and after 12 months). Aim 1: To determine whether the proposed biomarkers independently predict recurrent stroke among all patients. Hypothesis 1: Elevated levels of one or more of the proposed biomarkers will independently predict recurrent strokes during trial follow-up, assessed by structured interviews, as well as chart reviews 90 days and 1 year after the index stroke. Aim 2: To determine whether cardioembolic (CE) biomarkers are associated with atrial fibrillation among all patients. Hypothesis 2: Baseline values of one or more of the proposed 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 ambulatory cardiac rhythm monitors and structured interviews as well as chart reviews 90 days and 1 year after the index stroke. Aim 3: To determine whether large artery atherosclerosis (LAA) biomarkers are associated with a) the presence of cerebrovascular atherosclerosis among all patients. Hypothesis 3: Baseline values of one or more of the proposed LAA biomarkers will be independently associated with the presence of extra and intracranial atherosclerosis among patients with ischemic stroke, assessed by duplex sonography. Exploratory Aim 4: To determine whether the proposed biomarkers will predict b) new silent strokes and c) progression of chronic cerebral ischemic lesion (white matter hyper-intensity) volume (WMHV) among cryptogenic stroke patients. Hypothesis 4: Baseline values of one or more of the proposed biomarkers will independently predict a) silent stroke b) progression of WMHV, during study follow-up, assessed by repeated magnetic resonance imaging (MRI) (on admission, and 1 year after the index stroke). 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.
phase not implemented.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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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)
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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)
A location was updated in New York.
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The overall status was removed for Columbia University, Department of Neurology.
A location was updated in Frankfurt am Main.
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The overall status was removed for University Hospital of Frankfurt.
A location was updated in Mannheim.
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The overall status was removed for University Hospital of Mannheim.
A location was updated in Larissa.
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The overall status was removed for Larissa University Hospital of Thessaly.
A location was updated in Barcelona.
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The overall status was removed for Universitiy Hospital Vall d'Hebron.
A location was updated in Aarau.
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The overall status was removed for Kantonsspital Aarau, Department of Neurology.
A location was updated in Basel.
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The overall status was removed for University Hospital of Basel.
A location was updated in Bern.
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The overall status was removed for University Hospital of Bern/Inselspital.
A location was updated in Lausanne.
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The overall status was removed for University Hospital of Lausanne.
A location was updated in Lugano.
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The overall status was removed for Stroke Center ; Neurocentro(EOC) della Svizzera Italiana.
A location was updated in St.Gallen.
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The overall status was removed for Stroke Center, Kantonsspital St.Gallen.
A location was updated in Zurich.
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The overall status was removed for University Hospital of Zurich, Department of Neurology.
19 May '16
A location was updated in Frankfurt am Main.
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The overall status was removed for University Hospital of Frankfurt.
28 Jul '15
A location was updated in Mannheim.
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The overall status was removed for University Hospital of Mannheim.
A location was updated in Larissa.
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The overall status was removed for Larissa University Hospital of Thessaly.
A location was updated in Barcelona.
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The overall status was removed for Universitiy Hospital Vall d'Hebron.
A location was updated in Basel.
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The overall status was removed for University Hospital of Basel.
A location was updated in Bern.
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The overall status was removed for University Hospital of Bern/Inselspital.
A location was updated in Lausanne.
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The overall status was removed for University Hospital of Lausanne.