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Atherogenic Lipoproteins in Ischemic Stroke

AtheroGEnic LipoprotEinS in Ischemic Stroke: The AGELESS Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05090878
Acronym
AGELESS
Enrollment
500
Registered
2021-10-25
Start date
2021-09-20
Completion date
2025-12-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Apolipoprotein B (apoB), Lipoprotein(a) (Lp(a)), Low-density Lipoprotein Cholesterol (LDL-C), Very Low-density Lipoprotein (VLDL), Intraplaque Hemorrhage (IPH), Atherogenic lipoproteins, Dyslipidemia

Brief summary

Apolipoprotein B (apoB) levels (which encompass all atherogenic lipoproteins, including LDL), Lp(a) levels, and carotid IPH are associated with both first-ever and recurrent ischemic stroke. This cohort research project is to analyze: 1. Among patients with carotid artery atherosclerosis (stenosis 30-99%), to compare patients with and without IPH, as assessed by magnetic resonance (MR)-Plaque Imaging, in terms of apoB, Lp(a) levels and other cardiovascular risk factors. (IPH is a strong morphological sign of plaque vulnerability / instability and a strong marker of consecutive atheroembolic events). 2. Among patients with carotid artery atherosclerosis (stenosis 30-99%), to assess the risk of first-ever ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH, after adjusting for the cardiovascular factors (understanding this association can inform primary prevention). 3. Among patients with carotid artery atherosclerosis (stenosis 30-99%) with an ipsilateral ischemic stroke at baseline, to assess the risk of recurrent ipsilateral ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH, after adjusting for the cardiovascular factors. There will be a sensitivity analysis to assess if the association between Lp(a) and recurrent stroke is stronger in patients \<60 years of age. (understanding this association can inform secondary prevention). For the first and second aim, there will be a cross-sectional, case-control analysis. For the third aim, i.e. assessing recurrent ischemic stroke, there is prospective follow-up of at least 3 months up to 45 months.

Interventions

None listed

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Atherosclerotic carotid stenosis, North American Symptomatic Trial Collaborators (NASCET) method 30-99% * Ability to undergo a neck MR for carotid plaque imaging * Ability to undergo a follow-up of at least 1-year * For the prospective, longitudinal part: Hemispheric ischemic stroke or retinal ischemia ipsilateral to the carotid stenosis, with symptom onset within 24 hours (these patients will be followed-up for recurrent ischemic stroke)

Exclusion criteria

* Carotid stenosis due to causes other than atherosclerosis (e.g. carotid dissection or post-actinic) * Contraindication to MRI * Lack of informed consent

Design outcomes

Primary

MeasureTime frameDescription
Presence of carotid IPH on MR-Plaque imaging (3-Tesla MR scans with an 8-channel carotid coil)one time assessment at baseline (scan time is 5 minutes)Presence of carotid IPH on MR-Plaque imaging at baseline. Baseline means either acquired during the hospitalization for the index stroke or during the enrolling visit at the outpatient consultation of the neurovascular clinic of the University Hospital Basel (primary center) and Zurich (partner center).
Presence of an ischemic, hemispheric, ipsilateral stroke on baseline brain MR-Diffusion Weighted Imaging (DWI)one time assessment at baselinePresence of an ischemic, hemispheric, ipsilateral stroke, i.e. on the same side of the carotid stenosis, on baseline brain MR-DWI.
Presence of a recurrent ischemic, hemispheric, ipsilateral stroke in the 3-month follow-up brain MR-DWI3 months after baselinePresence of a recurrent ischemic, hemispheric, ipsilateral stroke in the 3-month follow-up brain. The 3-month follow-up brain MR-DWI is conceived to detect covert strokes, i.e. clinically asymptomatic strokes, as recurrences tend to occur short after the first stroke.

Countries

Switzerland

Contacts

Primary ContactGian Marco De Marchis, PD Dr. med.
gian.demarchis@usb.ch+41 61 265 25 25
Backup ContactSalome Rudin
salome.rudin@usb.ch+41 61 265 25 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026