Atherogenic Lipoproteins in Ischemic Stroke (AGELESS)

University Hospital Basel

Status: Enrolling

Conditions: Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT05090878

2021-01167 ko21Demarchis2;

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

1. Patients with and without carotid IPH

Description:

Among patients with carotid artery atherosclerosis (stenosis 30-99%), patients with and without IPH, as assessed by MR-Plaque Imaging, are compared in terms of apoB, Lp(a) levels and other cardiovascular risk factors.

2. Patients with and without first-ever ischemic stroke at baseline

Description:

Among patients with carotid artery atherosclerosis (stenosis 30-99%), the risk of first-ever ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH is assessed, after adjusting for the cardiovascular factors.

3. Patients with and without recurrent ischemic stroke

Description:

Among patients with carotid artery atherosclerosis (stenosis 30-99%) with an ipsilateral ischemic stroke at baseline, the risk of recurrent ipsilateral ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH is assessed, after adjusting for the cardiovascular factors.