Observational study of patients with recent ischemic stroke
Prospective Cohort With Incident Stroke
Ludwig-Maximilians - University of Munich · NCT01364168
This study is trying to see if new ways to predict the risk of having another stroke, heart attack, or dying can help people who have just had their first ischemic stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ludwig-Maximilians - University of Munich (other) |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT01364168 on ClinicalTrials.gov |
What this trial studies
This study aims to derive and validate risk scores for vascular endpoints such as recurrent stroke, myocardial infarction, and death following an incident stroke. Approximately 850 patients who have experienced their first acute ischemic stroke will be followed for 36 months, with assessments at baseline and at 3, 12, 24, and 36 months. The study will evaluate known predictors of vascular diseases and incorporate new biomarkers, including neuroimaging and blood-based markers, to improve predictive models. The models will be validated using bootstrap methods and an independent external sample from a related cohort.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced their first acute ischemic stroke within the last 7 days and can provide informed consent.
Not a fit: Patients with a history of prior strokes, brain tumors, or those participating in other intervention studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide improved risk assessment tools for patients who have suffered an ischemic stroke, potentially leading to better management and outcomes.
How similar studies have performed: Other studies have shown success in developing prognostic models for stroke outcomes, but this study aims to enhance existing models with new biomarkers, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Prior stroke (definition according to WHO criteria) * Patients presenting brain tumour or brain metastasis * Participation in an intervention- / AMG-study
Where this trial is running
Berlin and 1 other locations
- Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin — Berlin, Germany (ACTIVE_NOT_RECRUITING)
- Interdisciplinary Stroke Center Munich, Klinikum der Universität München — Munich, Germany (RECRUITING)
Study contacts
- Study coordinator: Martin Dichgans, Prof.
- Email: martin.dichgans@med.uni-muenchen.de
- Phone: +49 (0)89 4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke