Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05850247
Other study ID # 69HCL20_0403
Secondary ID 2023-504573-20
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date August 1, 2023
Est. completion date January 30, 2025

Study information

Verified date April 2023
Source Hospices Civils de Lyon
Contact Laura MECHTOUFF
Phone 4.27.85.67.47
Email laura.mechtouff@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date January 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients 18 years or over, - Signed written informed consent before any study specific intervention, - Probable ipsilateral transient ischemic attack (TIA - which involve a focal speech/language, motor or visual deficit referable to the distribution of a carotid artery and lasting less than 24 hours from the onset) OR ischemic stroke = 24h from the onset, - Atherosclerotic carotid stenosis between 50% and 99% (NASCET method), as confirmed by one of the imaging examinations (among: Doppler ultrasound, MR angiography, CT angiography, catheter angiography) performed after index TIA or ischemic stroke Exclusion Criteria: - Patients with inflammatory or autoimmune disease, hepatocellular insufficiency, acute or chronic infection, active malignancy, myocardial infarction or major surgery within the previous 30 days of index hospitalization according to the investigator, - Patients with severe renal insufficiency (estimated GFR < 30 ml/min at inclusion or known dialysis), - Patients with contraindication to MRI (agitation, claustrophobia, pacemaker, metallic (ferromagnetic) body, a known allergy to gadolinium) according to the investigator's judgment, - Patients with modified Rankin score greater than 3, - Patients currently enrolled in another clinical trial including investigational medicinal products, - Female patient who is pregnant or lactating, or is of child-bearing and who did not agree to use highly effective methods of birth control throughout the study, - Patient without health coverage, - Patient under legal protection

Study Design


Intervention

Drug:
[18F]DPA-714 PET
To assess the association between plasma ficolin-2 levels and plaque and brain inflammation assessed by [18F]DPA-714 PET/MRI in patients managed for transient ischaemic attack or ischaemic stroke related to carotid stenosis.

Locations

Country Name City State
France Service de Neurologie vasculaire / CarMeN U1060 INSERM Hôpital Neurologique Pierre Wertheimer - GHE Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between: - Plasma levels of ficolin-2 at day 5 in ng/ml, - Metabolic data on [18F]DPA-714 PET/MRI To assess the association between circulating levels of ficolin-2 and carotid and brain inflammation on [18F]DPA-714 PET/MRI in patients with transient ischemic attack or acute ischemic stroke due to carotid stenosis day 5
Secondary Correlation between plasma levels of ficolin-2 at day 5 in ng/mL with morphological data of the brain and carotid plaque assessed by MRI To assess if plasma levels of ficolin-2 in patients with TIA or acute ischemic stroke due to carotid stenosis correlate with:
1. morphological data:
of the plaque: presence of intraplaque hemorrhage, lipid-rich necrotic core, thinning/rupture of the fibrous cap on carotid plaque MRI
of the brain: infarct size, presence of hemorrhagic transformation, blood-brain barrier leakage
day 5
Secondary Correlation between plasma levels of ficolin-2 at day 5 in ng/mL with morphological data of the brain and carotid plaque assessed by MRI To assess if plasma levels of ficolin-2 in patients with TIA or acute ischemic stroke due to carotid stenosis correlate with:
- histological data of the retrieved plaque: hemorrhagic content, lipid core, cholesterol cleft areas, ratio between thickness of tunica media and total thickness of tunica, rupture, intraplaque deposition of ficolin-2, macrophages and neutrophils infiltration
day 15
See also
  Status Clinical Trial Phase
Recruiting NCT03631381 - Retrospective Study of Carotid Surgery in Dijon
Completed NCT05437991 - Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis N/A
Completed NCT02722720 - Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral N/A
Completed NCT02336958 - Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration N/A
Completed NCT02630862 - Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization N/A
Completed NCT00536796 - Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets N/A
Recruiting NCT05566301 - Multicentric Study on Clopidogrel Resistance in DAPT for CAS (MULTI-RESCLOSA)
Completed NCT03303534 - Short-Term Endogenous Hydrogen Sulfide Upregulation N/A
Completed NCT01480206 - Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR
Recruiting NCT05250349 - TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure
Recruiting NCT05845710 - Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III) N/A
Recruiting NCT01732523 - Predictive Value of Neovascularization Within Asymptomatic Carotis Stenosis on CEUS
Completed NCT01315288 - A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis N/A
Withdrawn NCT00401921 - A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy Phase 2
Recruiting NCT01273350 - A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin) N/A
Completed NCT03215550 - PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis
Completed NCT03215563 - PET-MRI Imaging in Patients With Acute Neurovascular Syndrome
Completed NCT04553549 - Safety and Feasibility of the Infinity Catheter for Radial Access
Completed NCT03596229 - Major Adverse Cardiac Events After Carotid Endarterectomy
Completed NCT04255316 - Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation N/A