Observational Dutch Young Symptomatic StrokE studY - nEXT (ODYSSEY-nEXT)

May 2, 2023 updated by: Radboud University Medical Center

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.

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Leeuwarden, Netherlands, 8934 AD
        • Not yet recruiting
        • Medisch Centrum Leeuwarden
        • Contact:
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7512 KZ
        • Not yet recruiting
        • Medisch Spectrum Twente
        • Contact:
      • Zwolle, Overijssel, Netherlands, 8025 AB
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands, 2545 AA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients aged 18 to 49 hospitalized due to first-ever imaging-positive ischemic stroke or transient ischemic attack.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and 3 month visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death from any cause
Time Frame: 10 years
10 years
Nonfatal or fatal recurrent cardiovascular (ischemic) events
Time Frame: 10 years
Ischemic stroke or transient ischemic attack, acute coronary syndrome, peripheral artery disease
10 years
Recurrent venous thrombotic events
Time Frame: 10 years
Deep venous thrombosis, pulmonary embolism, cerebral venous sinus thrombosis
10 years
Malignancy
Time Frame: 10 years
10 years
Bleeding complications
Time Frame: 10 years
Minor and major bleeding complications
10 years
Vessel wall imaging on 3T MRI
Time Frame: At baseline
Detection of vessel wall enhancement on MRI in young stroke patients
At baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale
Time Frame: at 3-month visit and at annual follow-up contacts from year 1 to year 10
Functional outcome will be assessed with modified Rankin Scale
at 3-month visit and at annual follow-up contacts from year 1 to year 10
Functional outcome will be assessed with Barthel Index
Time Frame: at 3-month visit and at annual follow-up contacts from year 1 to year 10.
at 3-month visit and at annual follow-up contacts from year 1 to year 10.
Coping strategies
Time Frame: at 3 months visit and 6 months
Questionnaire about different strategies to cope with major setbacks.
at 3 months visit and 6 months
Subjective cognitive outcome
Time Frame: at 6-month follow-up
Subjective cognition will be assessed with an electronic questionnaire
at 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Synapse bv

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Anticipated)

January 1, 2027

Study Completion (Anticipated)

January 1, 2037

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL77518.091.21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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