NCT02274727

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
4 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

7.3 years

First QC Date

October 17, 2014

Last Update Submit

November 5, 2021

Conditions

Stroke, Acute

Keywords

BiomarkerStrokeEtiologyOutcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Single components and combinations of MACE

    Within one year after the index stroke

  • Stroke aetiology

    During first hospitalisation (cross-sectional analysis, up to 14 days)

  • History of AF

    Diagnosed befor the stroke

  • Newly Atrial Fibrillation (AF)

    On admission and during a one year of follow-up by PCM. In Zurich and Basel also in 2021

  • The presence of cerebrovascular atherosclerosis among all patients.

    During first hospitalisation (cross-sectional analysis, up to 14 days)

Other Outcomes (5)

  • Functional outcome

    Within 3 month after the index stroke and at one year. In Zurich and Basel also in 2021

  • Occurrence of epileptic seizures and the diagnosis of epilepsy

    During 2021 (only in Zurich and Basel)

  • Ooccurrence of newly diagnosed cancer

    During 2021 (only in Zurich and Basel)

  • +2 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The BIOSIGNAL study will be a prospective observational multicenter cohort study to evaluate selected CE and LAA blood biomarkers in patients with incident ischemic stroke. We will consecutively recruit patients over a planned time period of two years. All participants will be followed for 1 year.

You may qualify if:

  • 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.
  • 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
  • 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.

You may not qualify if:

  • Hemorrhagic stroke
  • All patients discharged from the hospital with a diagnosis different from ischemic stroke (i.e. stroke mimics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Hospital of Frankfurt

Frankfurt am Main, 60590, Germany

Location

Larissa University Hospital of Thessaly

Larissa, 41110, Greece

Location

Universitiy Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Kantonsspital Aarau, Department of Neurology

Aarau, Canton of Aargau, 5001, Switzerland

Location

University Hospital of Basel

Basel, 4031, Switzerland

Location

University Hospital of Bern/Inselspital

Bern, 3010, Switzerland

Location

Stroke Center ; Neurocentro(EOC) della Svizzera Italiana

Lugano, 6900, Switzerland

Location

Stroke Center, Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

University Hospital of Zurich, Department of Neurology

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Cameron AC, Arnold M, Katsas G, Yang J, Quinn TJ, Abdul-Rahim AH, Campbell R, Docherty K, De Marchis GM, Arnold M, Kahles T, Nedeltchev K, Cereda CW, Kagi G, Bustamante A, Montaner J, Ntaios G, Foerch C, Spanaus K, Eckardstein AV, Dawson J, Katan M. Natriuretic Peptides to Classify Risk of Atrial Fibrillation Detection After Stroke: Analysis of the BIOSIGNAL and PRECISE Cohort Studies. Neurology. 2024 Aug 13;103(3):e209625. doi: 10.1212/WNL.0000000000209625. Epub 2024 Jul 1.

    PMID: 38950311DERIVED

  • Schweizer J, Arnold M, Konig IR, Bicvic A, Westphal LP, Schutz V, Inauen C, Scherrer N, Luft A, Galovic M, Ferreira Atuesta C, Pokorny T, Arnold M, Fischer U, Bonati LH, De Marchis GM, Kahles T, Nedeltchev K, Cereda CW, Kagi G, Bustamante A, Montaner J, Ntaios G, Sagris D, Foerch C, Spanaus K, von Eckardstein A, Katan M. Measurement of Midregional Pro-Atrial Natriuretic Peptide to Discover Atrial Fibrillation in Patients With Ischemic Stroke. J Am Coll Cardiol. 2022 Apr 12;79(14):1369-1381. doi: 10.1016/j.jacc.2022.01.042.

    PMID: 35393018DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mira Katan, MD, MS

    Name: Mira Katan, MD, Msc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 24, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

November 11, 2021

Record last verified: 2021-11

Locations

CH(6)DE(1)GR(1)ES(1)