Atherogenic Lipoproteins in Ischemic Stroke

NCT05090878 | Recruiting

• 1 other identifier: 2021-01167; ko21Demarchis2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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. 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. 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. 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).

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Carotid stenosis due to causes other than atherosclerosis (e.g. carotid dissection or post-actinic)
• Contraindication to MRI
• Lack of informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (2)

University Hospital Basel, Department of Neurology/Stroke Center

Basel, 4031, Switzerland

RECRUITING

University Hospital Zürich

Zurich, Switzerland

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological material (blood) in this project is not identified by participant name but by a unique participant number. Biological material is appropriately stored in a restricted area only accessible to authorized personnel.

MeSH Terms

Conditions

Ischemic Stroke; Dyslipidemias

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gian Marco De Marchis, PD Dr. med.

  Department of Neurology/Stroke Center; University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Marco De Marchis, PD Dr. med.

CONTACT

+41 61 265 25 25; gian.demarchis@usb.ch

Salome Rudin

CONTACT

+41 61 265 25 25; salome.rudin@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 25, 2021
• Study Start: September 20, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CH (2)