Clinical trial NCT05090878: Atherogenic Lipoproteins in Ischemic Stroke
Official title: AtheroGEnic LipoprotEinS in Ischemic Stroke: The AGELESS Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2021-10-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke will be recruited in the Stroke Unit of the University Hospital Basel (primary center) and Zurich (partner center). Patients without ischemic stroke will be recruited in the outpatient neurovascular clinic at the University Hospital Basel (primary center) and Zurich (partner center), where around 250 patients with known carotid stenosis are regularly followed-up - clinically and with ultrasound.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Presence of carotid IPH on MR-Plaque imaging (3-Tesla MR scans with an 8-channel carotid coil)
timeFrame: one time assessment at baseline (scan time is 5 minutes)
measure: Presence of an ischemic, hemispheric, ipsilateral stroke on baseline brain MR-Diffusion Weighted Imaging (DWI)
timeFrame: one time assessment at baseline
measure: Presence of a recurrent ischemic, hemispheric, ipsilateral stroke in the 3-month follow-up brain MR-DWI
timeFrame: 3 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Neurology/Stroke Center
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Department of Neurology/Stroke Center; University Hospital Basel
name: Gian Marco De Marchis, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: