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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05853796
Other study ID # NL77518.091.21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2023
Est. completion date January 1, 2037

Study information

Verified date May 2023
Source Radboud University Medical Center
Contact Frank-Erik De Leeuw, Prof.
Phone 0031650200314
Email frankerik.deleeuw@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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, 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


Recruitment information / eligibility

Status Recruiting
Enrollment 280
Est. completion date January 1, 2037
Est. primary completion date January 1, 2027
Accepts healthy volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Locations

Country Name City State
Netherlands HagaZiekenhuis Den Haag Zuid-Holland
Netherlands Catharina Ziekenhuis Eindhoven Noord-Brabant
Netherlands Medisch Spectrum Twente Enschede Overijssel
Netherlands Medisch Centrum Leeuwarden Leeuwarden
Netherlands Radboudumc Nijmegen Gelderland
Netherlands Isala Zwolle Overijssel

Sponsors (2)

Lead Sponsor Collaborator
Radboud University Medical Center Synapse bv

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Modified Rankin Scale 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
Other Functional outcome will be assessed with Barthel Index at 3-month visit and at annual follow-up contacts from year 1 to year 10.
Other Coping strategies Questionnaire about different strategies to cope with major setbacks. at 3 months visit and 6 months
Other Subjective cognitive outcome Subjective cognition will be assessed with an electronic questionnaire at 6-month follow-up
Primary Difference of concentration biomarkers and coagulation assays between patients and controls Biomarkers and assays of coagulation, inflammation and endothelium activation At baseline and 3 month visit
Secondary Nonfatal or fatal recurrent cardiovascular (ischemic) events Ischemic stroke or transient ischemic attack, acute coronary syndrome, peripheral artery disease 10 years
Secondary Recurrent venous thrombotic events Deep venous thrombosis, pulmonary embolism, cerebral venous sinus thrombosis 10 years
Secondary Death from any cause 10 years
Secondary Malignancy 10 years
Secondary Bleeding complications Minor and major bleeding complications 10 years
Secondary Vessel wall imaging on 3T MRI Detection of vessel wall enhancement on MRI in young stroke patients At baseline
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