NCT05853796 Observational Dutch Young Symptomatic StrokE studY - nEXT
| NCT ID | NCT05853796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-02-06 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 280 participants in total. It began in 2023-02-06 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
BACKGROUND: Worldwide, 2 million patients aged 18-50 years suffer an ischemic stroke each year with an increasing trend over the past decade due to yet unknown reasons. Whereas prognosis and antithrombotic treatment in older patients with cardiovascular disease are among the best studied topics in clinical medicine, this does not hold true for patients at young age. It is of great importance to treat these patient groups correctly to prevent recurrence and bleeding complications. However, previous research have shown that there is a long-term increased risk of recurrent ischemic events despite the secondary prevention and a subsequent increased bleeding risk. To tailor effective antithrombotic therapy to the individual patient, it is essential to understand the underlying pathogenesis and identify modifiable risk factors in young patients for recurrence or bleeding. It is thought that abnormalities of hemostasis may play a key role in early-onset ischemic stroke. First, prothrombotic conditions are associated with an increased risk for ischemic stroke at young age. In addition, disturbance of the hemostatic balance due to one or several triggers can activate the coagulation cascade, which on its turn can lead or contribute to clot formation and subsequent arterial occlusion. In previous study, there were indications that trigger factors such as fever and/or an infection in the days prior to the stroke may play a role in the pathogenesis. This suggests that an interaction between inflammation, endothelial damage and coagulation may lead to the formation of a clot. In this observational study we aim to investigate the role of the immune system, endothelial damage and coagulation in the pathogenesis and prognosis of stroke in young patients. OBJECTIVE: To investigate the role of hemostasis, inflammation and endothelial activation in the etiology and prognosis in an acute ischemic stroke (or TIA) in young stroke patients. STUDY DESIGN: Multicentre prospective observational study STUDY POPULATION: All patients aged between 18 and 50 years old with a first-ever ischemic stroke or TIA who are admitted to the neurology ward or seen at the outpatient clinic of one of the participating centers. Main exclusion criteria are: history of clinical TIA, ischemic stroke or intracerebral hemorrhage. A intracerebral hemorrhage resulting from trauma, known aneurysm or underlying intracerebral malignancy. A venous infarction, retinal infarction and amourosis fugax. Inadequate control of the Dutch language to reliably sign an informed consent from and/or participate in the follow-up. Patients are excluded if they have a contra indication for 3T MRI. In addition 60 healthy controls (18-50 years old) will be included. MAIN STUDY ENDPOINTS: 1. Baseline and 3 months coagulation profile: Whole blood and platelet poor plasma thrombin generation, platelet function tests, and coagulation biomarkers, screening for thrombophilia. 2. Baseline and 3 months inflammation/endothelial activation profile: Cytokines/chemokines, expression of receptors/cofactors related to hemostasis on peripheral blood mononuclear cells (PBMCs), stimulation tests of PBMC's to assess trained immunity. 3. Vessel wall enhancement on 3 Tesla MRI 4. Questionnaire trigger factors
Eligibility Criteria
Inclusion Criteria: * Patients with a first-ever transient ischemic attack (TIA) or acute ischemic stroke aged between 18 and 50 years old * For this study, acute stroke is defined as "occurence of acute neurological deficit lasting more than 24 hours, with confirmation on imaging (CT(-a) or MR(-a))".TIA is defined as "occurence of acute neurological deficit lasting less than 24 hours with confirmation of ischemia on MRI). * Patients have a kidney function eGFR\>30ml/min. Exclusion Criteria: * A history of clinical TIA, ischemic stroke or intracerebral hemorrhage * A intracerebral hemorrhage resulting from trauma, known aneurysm or underlying intracerebral malignancy. * A venous infarction, retinal infarction or amourosis fugax. * Inadequate control of the Dutch language to reliably sign an informed consent from and/or participate in the follow-up * Patients are excluded if they have a contra indication for 3T MRI.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05853796 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05853796 currently recruiting?
Yes, NCT05853796 is actively recruiting participants. Contact the research team at frankerik.deleeuw@radboudumc.nl for enrollment information.
Where is the NCT05853796 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Eindhoven, Netherlands, Enschede, Netherlands, Zwolle, Netherlands and 2 additional locations.
Who is sponsoring the NCT05853796 clinical trial?
NCT05853796 is sponsored by Radboud University Medical Center. The trial plans to enroll 280 participants.
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