Ischemic StrokeODYSSEY-nEXTNCT05853796
Observational Dutch Young Symptomatic StrokE studY - nEXT
An observational study of Ischemic Stroke and Stroke in the Young, run by Radboud University Medical Center at 6 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ischemic Stroke, Stroke in the Young, Cardiovascular Diseases
- How many people
- 280 participants
- Where
- 6 sitesNetherlands
- Study dates
- 6 Feb 2023to 1 Jan 2037
- 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 to 50 years
- All sexes
- Adult
Study population: Patients aged 18 to 49 hospitalized due to first-ever imaging-positive ischemic stroke or transient ischemic attack.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Janneke Spiegelenberg, MD contact
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Not yet recruiting
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Ingeborg van Uden, MD, PhD, Inge.vanUden@radboudumc.nl
- Not yet recruiting
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
Renate Arntz, MD, PhD, renate.arntz@mst.nl
- Not yet recruiting
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
Frank Van Rooij, MD, PhD, frank.van.rooij@mcl.nl
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Janneke Spiegelenberg, MD, +31650200314, janneke.spiegelenberg@radboudumc.nl
Esmee Verburgt, esmee.verburgt@radboudumc.nl
- Not yet recruiting
HagaZiekenhuis
The Hague, South Holland, 2545 AA
Karlijn De Laat, MD, PhD, k.delaat@hagaziekenhuis.nl
- Not yet recruiting
Isala
Zwolle, Overijssel, 8025 AB
Heleen Den Hertog, MD, PhD, m.h.den.hertog@isala.nl
About this study
Official title: Observational Dutch Young Symptomatic StrokE studY - Extended
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.
Read more
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:
- Baseline and 3 months coagulation profile: Whole blood and platelet poor plasma thrombin generation, platelet function tests, and coagulation biomarkers, screening for thrombophilia.
- 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.
- Vessel wall enhancement on 3 Tesla MRI
- Questionnaire trigger factors
- Conditions
- Ischemic Stroke, Stroke in the Young, Cardiovascular Diseases, Cerebrovascular Disorders, Embolism and Thrombosis, Thrombophilia
- Medical subject headings
- Ischemic Stroke, Cardiovascular Diseases, Cerebrovascular Disorders, Embolism and Thrombosis, Thrombophilia, Thrombosis
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 |
|---|---|---|
| Patients with acute ischemic stroke at young age (18-50 years) | Patients aged 18 to 50 years with first-ever ischemic stroke or transient ischemic attack. | |
| Healthy controls | Healthy controls (aged 18 to 50 years) without cardiovascular diseases in their medical history. Subjects age- and gender-matched to patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of concentration biomarkers and coagulation assays between patients and controls
Biomarkers and assays of coagulation, inflammation and endothelium activation
Measured: At baseline and 3 month visit
Secondary outcomes (6)
Nonfatal or fatal recurrent cardiovascular (ischemic) events
Ischemic stroke or transient ischemic attack, acute coronary syndrome, peripheral artery disease
Measured: 10 years
Recurrent venous thrombotic events
Deep venous thrombosis, pulmonary embolism, cerebral venous sinus thrombosis
Measured: 10 years
Death from any cause
Measured: 10 years
Malignancy
Measured: 10 years
Bleeding complications
Minor and major bleeding complications
Measured: 10 years
Vessel wall imaging on 3T MRI
Detection of vessel wall enhancement on MRI in young stroke patients
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start6 Feb 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Synapse bv
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853796
- Sponsor's protocol ID
- NL77518.091.21
- Acronym
- ODYSSEY-nEXT
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Spiegelenberg JP, Verburgt E, den Hertog H, de Laat KF, van Rooij FG, van Uden IWM, Arntz RM, van den Wijngaard IR, Kessels RPC, Piai V, van der Kolk A, Roest M, de Laat B, Middeldorp S, Tuladhar A, Leentjens J, de Leeuw FE. 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. BMJ Open. 2025 Mar 21;15(3):e096330. doi: 10.1136/bmjopen-2024-096330.
PubMed 40118475
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Dutch Young Symptomatic StrokE studY - Extended
- ClinicalTrials.gov ID
- NCT05853796
- Acronym / sponsor ID
- ODYSSEY-nEXT / NL77518.091.21
- Conditions
- Ischemic Stroke, Stroke in the Young, Cardiovascular Diseases, Cerebrovascular Disorders, Embolism and Thrombosis, Thrombophilia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Synapse bv
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2037 (estimated)
- First posted
- 11 May 2023 (actual)
- 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.
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:
- Baseline and 3 months coagulation profile: Whole blood and platelet poor plasma thrombin generation, platelet function tests, and coagulation biomarkers, screening for thrombophilia.
- 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.
- Vessel wall enhancement on 3 Tesla MRI
- Questionnaire trigger factors
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ischemic stroke at young age (18-50 years) | – | –Patients aged 18 to 50 years with first-ever ischemic stroke or transient ischemic attack. |
| Healthy controls | – | –Healthy controls (aged 18 to 50 years) without cardiovascular diseases in their medical history. Subjects age- and gender-matched to patients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients aged 18 to 49 hospitalized due to first-ever imaging-positive ischemic stroke or transient ischemic attack.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Difference of concentration biomarkers and coagulation assays between patients and controls
Time frame: At baseline and 3 month visit
Biomarkers and assays of coagulation, inflammation and endothelium activation
6 secondary outcomes
Nonfatal or fatal recurrent cardiovascular (ischemic) events
Time frame: 10 years
Recurrent venous thrombotic events
Time frame: 10 years
Death from any cause
Time frame: 10 years
Malignancy
Time frame: 10 years
Bleeding complications
Time frame: 10 years
Vessel wall imaging on 3T MRI
Time frame: At baseline
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 11 May 2023.
- Derived from this study: PubMed 40118475Spiegelenberg JP, Verburgt E, den Hertog H, de Laat KF, van Rooij FG, van Uden IWM, Arntz RM, van den Wijngaard IR, Kessels RPC, Piai V, van der Kolk A, Roest M, de Laat B, Middeldorp S, Tuladhar A, Leentjens J, de Leeuw FE. 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. BMJ Open. 2025 Mar 21;15(3):e096330. doi: 10.1136/bmjopen-2024-096330.
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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.
Janneke Spiegelenberg, MD contact
6 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 and Stroke in the Young, run by Radboud University Medical Center at 6 sites in Netherlands.
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 3 inclusion and 5 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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 Frank-Erik De Leeuw, Prof. (0031650200314, frankerik.deleeuw@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of concentration biomarkers and coagulation assays between patients and controls (time frame: At baseline and 3 month visit). 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 NCT05853796, which also lists 1 linked publication.
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 11 May 2023.