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Plaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the Ficolin-2

Study acronym: STATEMENT
StatusRecruiting
PhasePhase 2
Started2024-02-13
View on ClinicalTrials.gov ↗

Amendment history

2025-02-03
minor
Study Status, Arms and Interventions, Eligibility v3
Primary completion date2025-06-09→2026-12-31
Completion date2025-06-09→2026-12-31
Start date2024-02-09→2024-02-13
Interventions[18F]DPA-714 PET (Drug)→[18F]DPA-714 PET/MRI (Drug)
Eligibility criteria+113 characters
[...] the distribution of a carotid artery and lasting less than 2448 hours from the onset) OR retinal artery occlusion ≤ 48h OR ischemic stroke ≤ 24h48h from the onset, Atherosclerotic carotid stenosis between 50 [...] r angiography) performed after index TIA or ischemic stroke No other identified cause of TIA, ischemic stroke or retinal artery occlusion, Exclusion Criteria: Patients with inflammatory or autoimmune [...]
2024-12-03
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-12-31→2025-06-09
Completion date2025-01-30→2025-06-09
Start dateestimated 2023-08-01→confirmed 2024-02-09
Study sitesdetails revised at 1 of 1 site
2023-05-11
minor
Study Status, Study Description v1
Re-verified, no change to tracked fields
2023-04-28
minor
Original filing
Carotid artery stenosis is observed in about 3% of ≥ 60 years subjects and accounts for around 10-20% of all ischemic strokes. Beyond the degree of stenosis, plaque composition affects the risk of ischemic stroke. Identification of patients with vulnerable plaques at higher risk of stroke who might benefit from carotid revascularization is crucial. A growing body of evidence suggests that the lectin pathway of the complement system, and especially the ficolin-2, is involved in atherosclerosis. It has been hypothesized that circulating levels of ficolin-2 increase during chronic inflammatory conditions (i.e. growing atherosclerotic plaque) whereas they fall during sub-acute or acute inflammatory conditions (i.e. plaque rupture and acute ischemic stroke) because of consumption (binding to targets). Therefore, ficolin-2 has been proposed as a biomarker informing on the specific state of the plaque. However, in acute ischemic stroke due to carotid stenosis, both plaque rupture and stroke injury contribute to lectin pathway activation, thus affecting circulating levels of ficolin-2. Until now, the relative contribution of plaque and brain inflammation on circulating levels of ficolin-2 has not been documented. In the present study the investigators aim to assess the association between circulating levels of ficolin-2 and carotid and brain inflammation on \[18F\]DPA-714 positron emission tomography (PET)/MRI in patients with transient ischemic attack or acute ischemic stroke due to carotid stenosis. For that purpose, the investigators intend to include 30 patients with transient ischemic attack or acute ischemic stroke due to ≥ 50%. carotid stenosis. Each patient will have a measure of plasmatic level of ficolin-2 as well a \[18F\]DPA-714 PET/MRI to quantify the fixation of the radiotracer on carotid and brain.
Trial Details
NCT Number NCT05850247
Lead Sponsor Hospices Civils de Lyon
Conditions CAROTID STENOSIS
Enrollment 20 participants
Start Date 2024-02-13
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-06