NCT05853796: ODYSSEY-nEXT

Observational Dutch Young Symptomatic StrokE studY - nEXT

Recruiting now Last updated 11 May 2023

What this trial tests

trial in Ischemic Stroke in 280 participants. Currently enrolling.

Timeline

6 February 2023

Primary endpoint
1 January 2027

1 January 2037

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	280
Start date	6 February 2023
Primary completion	1 January 2027
Estimated completion	1 January 2037
Sites	6 locations across Netherlands

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →
• Stroke in the Young — all drugs for Stroke in the Young →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Cerebrovascular Disorders — all drugs for Cerebrovascular Disorders →

Sponsor

Radboud University Medical Center

Who can join

Adults 18 to 50, any sex, with Ischemic Stroke or Stroke in the Young. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Role of inflammation and haemostasis on aetiology and prognosis in young patients with ischaemic stroke: study protocol of the Observational Dutch Young Symptomatic StrokE study-EXTended (ODYSSEY-nEXT) - a multicentre prospective cohort study.
   Spiegelenberg JP, Verburgt E, den Hertog H, de Laat KF, et al · · 2025 · cited 1× · PMID 40118475 · DOI 10.1136/bmjopen-2024-096330