Ischemic StrokePROSCISNCT01364168
Prospective Cohort With Incident Stroke
An observational study of Ischemic Stroke, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 850 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2011to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to a specialized stroke service because of an acute stroke
Who may be able to join
- 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
Who cannot join
- Prior stroke (definition according to WHO criteria)
- Patients presenting brain tumour or brain metastasis
- Participation in an intervention- / AMG-study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 1 recruiting
- Active, not recruiting
Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin
Berlin, 10117
- Recruiting
Interdisciplinary Stroke Center Munich, Klinikum der Universität München
Munich, 81377
Martin Dichgans, Prof., +49 (0)89 4400 ext. 46019, martin.dichgans@med.uni-muenchen.de
Martin Dichgans, Prof.
About this study
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.
Read the detailed description
Risk of vascular disease including stroke, myocardial infarction, and vascular death is high after stroke but there are only few prognostic models for long term risk up to 3 years. About 850 patients with an incident stroke will be followed for 3 years with assessments at baseline and at 3, 12, 24, and 36 months. Factors that have already been reported to be significant predictors of vascular diseases in previous studies as well as new biomarkers (e.g. neuroimaging, blood based biomarkers) identified in this cohort will be considered. The improvement of discrimination including these new variables in the models will be investigated. Several measures of improving predictive properties (e.g. calibration, discrimination, net reclassification) will be used to compare predictive models with different complexity. The model will be validated using the bootstrap method (internal validation) and an independent external sample in cooperation with the prospective CSB-stroke cohort.
- Conditions
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (4)
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. In case of death of the patient, evaluation will be based on data from the registry office.
Measured: 24 months
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 the physician. In case of death of the patient, evaluation will be based on data from the registry office.
Measured: 12 months
Course of cognitive function
This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by the physician.
Measured: 36 months
Course of depression
This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by the physician.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2024 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Martin Dichgans, Ludwig-Maximilians - University of Munich
- Investigators
- Martin Dichgans, Prof., Study chair, Institute for Stroke and Dementia Research, Klinikum der Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364168
- Sponsor's protocol ID
- ISD-PROSCIS-01
- Acronym
- PROSCIS
- Status last verified
- Mar 2024
- First submitted
- 31 May 2011
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22928669Malsch 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.
PubMed 30256828
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort With Incident Stroke
- ClinicalTrials.gov ID
- NCT01364168
- Acronym / sponsor ID
- PROSCIS / ISD-PROSCIS-01
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Feb 2011 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Risk of vascular disease including stroke, myocardial infarction, and vascular death is high after stroke but there are only few prognostic models for long term risk up to 3 years. About 850 patients with an incident stroke will be followed for 3 years with assessments at baseline and at 3, 12, 24, and 36 months. Factors that have already been reported to be significant predictors of vascular diseases in previous studies as well as new biomarkers (e.g. neuroimaging, blood based biomarkers) identified in this cohort will be considered. The improvement of discrimination including these new variables in the models will be investigated. Several measures of improving predictive properties (e.g. calibration, discrimination, net reclassification) will be used to compare predictive models with different complexity. The model will be validated using the bootstrap method (internal validation) and an independent external sample in cooperation with the prospective CSB-stroke cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to a specialized stroke service because of an acute stroke
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Prior stroke (definition according to WHO criteria)
- Patients presenting brain tumour or brain metastasis
- Participation in an intervention- / AMG-study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death
Time frame: 36 months
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.
4 secondary outcomes
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death
Time frame: 24 months
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death
Time frame: 12 months
Course of cognitive function
Time frame: 36 months
Course of depression
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 22928669Liman 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.
- Results publication: PubMed 30256828Malsch 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Dichgans, Prof. study chair
Institute for Stroke and Dementia Research, Klinikum der Universität München
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Dichgans, Prof. (+49 (0)89 4400 ext. 46019, martin.dichgans@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01364168, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.