Ischemic StrokeAGELESSNCT05090878
Atherogenic Lipoproteins in Ischemic Stroke
An observational study of Ischemic Stroke, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 500 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 20 Sep 2021to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Carotid stenosis due to causes other than atherosclerosis (e.g. carotid dissection or post-actinic)
- Contraindication to MRI
- Lack of informed consent
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel, Department of Neurology/Stroke Center
Basel, 4031
Gian Marco De Marchis, PD Dr. med., +41 61 265 25 25, gian.demarchis@usb.ch
Salome Rudin, +41 61 265 25 25, salome.rudin@usb.ch
- Not yet recruiting
University Hospital Zürich
Zurich
Susanne Wegener, Prof. Dr. med., +41 79 741 51 66, susanne.wegener@usz.ch
Susanne Wegener, Prof. Dr. med.
About this study
Official title: 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:
Read more
- 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).
- 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).
- 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.
- 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
- Medical subject headings
- Ischemic Stroke, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Presence of an ischemic, hemispheric, ipsilateral stroke, i.e. on the same side of the carotid stenosis, on baseline brain MR-DWI.
Measured: one time assessment at baseline
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.
Measured: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start20 Sep 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Gian Marco De Marchis, PD Dr. med., Principal investigator, Department of Neurology/Stroke Center; University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090878
- Sponsor's protocol ID
- 2021-01167; ko21Demarchis2
- Acronym
- AGELESS
- Status last verified
- Feb 2024
- First submitted
- 6 Oct 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtheroGEnic LipoprotEinS in Ischemic Stroke: The AGELESS Study
- ClinicalTrials.gov ID
- NCT05090878
- Acronym / sponsor ID
- AGELESS / 2021-01167; ko21Demarchis2
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Carotid stenosis due to causes other than atherosclerosis (e.g. carotid dissection or post-actinic)
- Contraindication to MRI
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gian Marco De Marchis, PD Dr. med. principal investigator
Department of Neurology/Stroke Center; University Hospital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gian Marco De Marchis, PD Dr. med. (+41 61 265 25 25, gian.demarchis@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.