Atherogenic Lipoproteins in Ischemic Stroke

Ischemic Stroke Clinical Trial

— AGELESS  

Official title:

AtheroGEnic LipoprotEinS in Ischemic Stroke: The AGELESS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090878
• Other study ID #: 2021-01167; ko21Demarchis2
• Status: Recruiting
• Start date: September 20, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Gian Marco De Marchis, PD Dr. med.
• Phone: +41 61 265 25 25
• Email: gian.demarchis[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Neurology/Stroke Center	Basel
Switzerland	University Hospital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of carotid IPH on MR-Plaque imaging (3-Tesla MR scans with an 8-channel carotid coil)	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).	one time assessment at baseline (scan time is 5 minutes)
Primary	Presence of an ischemic, hemispheric, ipsilateral stroke on baseline brain MR-Diffusion Weighted Imaging (DWI)	Presence of an ischemic, hemispheric, ipsilateral stroke, i.e. on the same side of the carotid stenosis, on baseline brain MR-DWI.	one time assessment at baseline
Primary	Presence of a recurrent ischemic, hemispheric, ipsilateral stroke in the 3-month follow-up brain MR-DWI	Presence 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.	3 months after baseline