NCT01363856

Brief Summary

The primary aim of the study is to derive and validate risk scores for vascular endpoints (recurrent stroke, myocardial infarction, and other complications of stroke) and for death following an incident stroke. For this purpose patients with an incident stroke will be followed for 36 months with additional assessments at 12, 24 and 36 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 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

February 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 2, 2011

Status Verified

May 1, 2011

Enrollment Period

3.3 years

First QC Date

May 31, 2011

Last Update Submit

June 1, 2011

Conditions

Stroke

Keywords

first ever stroke

Outcome Measures

Primary Outcomes (1)

  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death

    This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by hospital or physician.

    36 months

Secondary Outcomes (4)

  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death

    24 months

  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death

    12 months

  • Course of cognitive function

    36 months

  • Course of depression

    36 months

Study Arms (1)

First ever acute stroke

Patients over 18 years and without prior stroke according to WHO criteria, displaying an ischemic stroke, onset within the last 7 days, language German

Eligibility Criteria

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

Patients admitted to a specialized stroke service because of an acute stroke

You may qualify if:

  • Age ≥18 years
  • Language: German
  • First ever stroke including ischemic stroke, primary intracranial hemorrhage and cerebral venous sinus thrombosis that occurred with stroke onset in the last 7 days
  • Written informed consent by patient prior to study participation
  • Willingness to participate in follow-up

You may not qualify if:

  • Prior stroke (definition according to WHO definition)
  • Patients presenting brain tumour or brain metastasis
  • Participation in an intervention- / AMG-study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern

Munich, Germany

RECRUITING

Related Publications (10)

  • Giesers NK, Schaeff V, Gertz K, Endres M, Liman TG. Associations of Soluble Inflammatory and Endothelial Activation Biomarkers with Cognitive Function Over Three Years After Ischemic Stroke-PROSCIS-B. Transl Stroke Res. 2025 Dec;16(6):2249-2257. doi: 10.1007/s12975-025-01388-4. Epub 2025 Oct 8.

    PMID: 41057606DERIVED

  • Rios AS, Temuulen U, Khalil AA, Villringer K, Ali HF, Akdeniz A, Grittner U, Becher M, Rackoll T, Nave AH, Sperber PS, Liman TG, Otte C, Endres M, Kufner A. Lesion-Network Mapping of Poststroke Depressive Symptoms: Evidence From Two Prospective Ischemic Stroke Cohorts. Stroke. 2025 Sep;56(9):2527-2539. doi: 10.1161/STROKEAHA.125.051858. Epub 2025 Jul 7.

    PMID: 40620229DERIVED

  • Liman TG, Siegerink B, Piper S, Catar R, Moll G, Riemekasten G, Heidecke H, Heuschmann PU, Elkind MSV, Dragun D, Endres M. Vasoregulatory Autoantibodies and Clinical Outcome After Ischemic Stroke-PROSCIS-B. J Am Heart Assoc. 2023 Dec 5;12(23):e032441. doi: 10.1161/JAHA.123.032441. Epub 2023 Nov 28.

    PMID: 38014691DERIVED

  • Schaeff VLK, Sperber PS, Piper SK, Giesers NK, Gertz K, Heuschmann PU, Endres M, Liman TG. Associations of C-reactive protein with depressive symptoms over time after mild to moderate ischemic stroke in the PROSCIS-B cohort. J Neurol. 2024 Feb;271(2):909-917. doi: 10.1007/s00415-023-12038-w. Epub 2023 Oct 18.

    PMID: 37848651DERIVED

  • Stillfried MRV, Sperber PS, Broersen LHA, Huo S, Piper SK, Heuschmann PU, Endres M, Siegerink B, Liman TG. Low ankle-brachial index and cognitive function after stroke-the PROSpective with Incident Stroke Berlin (PROSCIS-B). Front Neurol. 2022 Sep 28;13:963262. doi: 10.3389/fneur.2022.963262. eCollection 2022.

    PMID: 36247749DERIVED

  • Scheitz JF, Lim J, Broersen LHA, Ganeshan R, Huo S, Sperber PS, Piper SK, Heuschmann PU, Audebert HJ, Nolte CH, Siegerink B, Endres M, Liman TG. High-Sensitivity Cardiac Troponin T and Recurrent Vascular Events After First Ischemic Stroke. J Am Heart Assoc. 2021 May 18;10(10):e018326. doi: 10.1161/JAHA.120.018326. Epub 2021 May 13.

    PMID: 33982599DERIVED

  • Huo S, Krankel N, Nave AH, Sperber PS, Rohmann JL, Piper SK, Heuschmann PU, Landmesser U, Endres M, Siegerink B, Liman TG. Endothelial and Leukocyte-Derived Microvesicles and Cardiovascular Risk After Stroke: PROSCIS-B. Neurology. 2021 Feb 9;96(6):e937-e946. doi: 10.1212/WNL.0000000000011223. Epub 2020 Nov 12.

    PMID: 33184230DERIVED

  • Broersen LHA, Siegerink B, Sperber PS, von Rennenberg R, Piper SK, Nolte CH, Heuschmann PU, Endres M, Scheitz JF, Liman TG. High-Sensitivity Cardiac Troponin T and Cognitive Function in Patients With Ischemic Stroke. Stroke. 2020 May;51(5):1604-1607. doi: 10.1161/STROKEAHA.119.028410. Epub 2020 Apr 13.

    PMID: 32279621DERIVED

  • Sperber PS, Siegerink B, Huo S, Rohmann JL, Piper SK, Pruss H, Heuschmann PU, Endres M, Liman TG. Serum Anti-NMDA (N-Methyl-D-Aspartate)-Receptor Antibodies and Long-Term Clinical Outcome After Stroke (PROSCIS-B). Stroke. 2019 Nov;50(11):3213-3219. doi: 10.1161/STROKEAHA.119.026100. Epub 2019 Sep 17.

    PMID: 31526121DERIVED

  • Liman TG, Zietemann V, Wiedmann S, Jungehuelsing GJ, Endres M, Wollenweber FA, Wellwood I, Dichgans M, Heuschmann PU. Prediction of vascular risk after stroke - protocol and pilot data of the Prospective Cohort with Incident Stroke (PROSCIS). Int J Stroke. 2013 Aug;8(6):484-90. doi: 10.1111/j.1747-4949.2012.00871.x. Epub 2012 Aug 29.

    PMID: 22928669DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA whole blood, serum, RNA

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Peter U Heuschmann, MD MPH

    Center for Stroke Research Berlin, Charité Campus Mitte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter U Heuschmann, MD, MPH

CONTACT

0049 (0)30 450560611peter.heuschmann@charite.dwe

Thomas G Liman, MD

CONTACT

49 (0)30 450560643thomas.liman@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

February 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2015

Last Updated

June 2, 2011

Record last verified: 2011-05

Locations

DE(2)