Actively Recruiting
Led by Radboud University Medical Center · Updated on 2023-05-11
280
Participants Needed
6
Research Sites
521 weeks
Total Duration
R
Radboud University Medical Center
Lead Sponsor
S
Synapse bv
Collaborating Sponsor
Researchers are studying the causes and outcomes of ischemic stroke or transient ischemic attack (TIA) in young adults aged 18 to 50 years. This observational study aims to understand how blood clotting, inflammation, and damage to blood vessel linings contribute to stroke in this age group. The study also explores how these factors affect the risk of stroke recurrence and bleeding complications over time. The study includes two groups: patients aged 18 to 50 who have had a first-ever ischemic stroke or TIA, and healthy controls of the same age range without cardiovascular disease. Researchers will collect blood samples at the start and after three months to analyze clotting and inflammation markers. Participants will also undergo 3 Tesla MRI scans to assess blood vessel walls and complete questionnaires about possible stroke triggers. Participants will be involved in evaluations at baseline and three months, including blood tests for coagulation and inflammation, MRI scans, and questionnaires. Researchers will track participants for up to 10 years to monitor recurrent cardiovascular events, venous thrombosis, malignancy, bleeding complications, and overall survival. The study will compare findings between stroke patients and healthy controls to better understand stroke mechanisms in young adults.
CONDITIONS
Observational Dutch Young Symptomatic StrokE studY - nEXT
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline visit
Participants undergo baseline assessments including blood biomarker measurements and vessel wall imaging with 3T MRI.
1 visit (in-person)
Duration - Up to 10 years
Participants are observed for recurrent cardiovascular events, venous thrombotic events, malignancy, bleeding complications, and death over time.
1 visit at 3 months and periodic follow-up visits during 10 years
Total: 6 locations
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
2
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623 EJ
Not Yet Recruiting
3
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7512 KZ
Not Yet Recruiting
4
Isala
Zwolle, Overijssel, Netherlands, 8025 AB
Not Yet Recruiting
5
HagaZiekenhuis
The Hague, South Holland, Netherlands, 2545 AA
Not Yet Recruiting
6
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Not Yet Recruiting
F
Frank-Erik De Leeuw, Prof.
J
Janneke Spiegelenberg, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Janneke P Spiegelenberg, Esmée Verburgt, Heleen den Hertog...
https://pubmed.ncbi.nlm.nih.gov/40118475