Atherogenic Lipoproteins in Ischemic Stroke (AGELESS)

February 23, 2024 updated by: University Hospital, Basel, Switzerland

AtheroGEnic LipoprotEinS in Ischemic Stroke: The AGELESS Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel, Department of Neurology/Stroke Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gian Marco De Marchis, Prof. Dr. med.
        • Sub-Investigator:
          • Tolga Daniel Dittrich, Dr. med.
      • Zürich, Switzerland
        • Not yet recruiting
        • University Hospital Zurich
        • Contact:
        • Principal Investigator:
          • Susanne Wegener, Prof. Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1. Patients with and without carotid IPH
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of carotid IPH on MR-Plaque imaging (3-Tesla MR scans with an 8-channel carotid coil)
Time Frame: 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).
one time assessment at baseline (scan time is 5 minutes)
Presence of an ischemic, hemispheric, ipsilateral stroke on baseline brain MR-Diffusion Weighted Imaging (DWI)
Time Frame: one time assessment at baseline
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
Presence of a recurrent ischemic, hemispheric, ipsilateral stroke in the 3-month follow-up brain MR-DWI
Time Frame: 3 months after baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

Investigators

  • Principal Investigator: Gian Marco De Marchis, PD Dr. med., Department of Neurology/Stroke Center; University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01167; ko21Demarchis2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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