NCT01364168

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 3, 12, 24 and 36 months.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress92%
Feb 2011Dec 2027

Study Start

First participant enrolled

February 1, 2011

Completed
4 months 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
13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

13.8 years

First QC Date

May 31, 2011

Last Update Submit

March 18, 2024

Conditions

Ischemic 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 ischemic 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 acute ischemic stroke 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 criteria)
  • 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, 10117, Germany

ACTIVE NOT RECRUITING

Interdisciplinary Stroke Center Munich, Klinikum der Universität München

Munich, 81377, Germany

RECRUITING

Related Publications (2)

  • 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: 22928669BACKGROUND

  • Malsch C, Liman T, Wiedmann S, Siegerink B, Georgakis MK, Tiedt S, Endres M, Heuschmann PU. Outcome after stroke attributable to baseline factors-The PROSpective Cohort with Incident Stroke (PROSCIS). PLoS One. 2018 Sep 26;13(9):e0204285. doi: 10.1371/journal.pone.0204285. eCollection 2018.

    PMID: 30256828RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, RNA

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Dichgans, Prof.

    Institute for Stroke and Dementia Research, Klinikum der Universität München

    STUDY CHAIR

Central Study Contacts

Martin Dichgans, Prof.

CONTACT

+49 (0)89 4400martin.dichgans@med.uni-muenchen.de

Study Design

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

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2024

Study Completion (Estimated)

December 1, 2027

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

DE(2)