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NEOVASC-LPA

NL-010254/R029408 - NEOVASC-LPA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57996
Enrollment
60
Registered
2025-06-17
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid artery disease

Interventions

Not applicable.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Adult individuals aged 18 years or older.Presence of atherosclerotic plaque in at least one carotid artery, as identified by prior CT angiography or carotid ultrasound.Plasma Lp(a) level determined at the screening visit, as measured by the Central Laboratory of the Amsterdam UMC:High-Lp(a) group: Lp(a) =125 nmol/LLow-Lp(a) group: Lp(a) <50 nmol/LCapable of safely undergoing MRI with gadolinium contrast.Willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: History of ipsilateral carotid revascularization (e.g., carotid endarterectomy or stenting).Active infection, autoimmune or systemic inflammatory disease, or malignancy (excluding localized skin cancer) that could confound imaging or inflammatory readouts, as judged by the investigator(s).Severe claustrophobia, precluding successful study participation.Inability to remain supine, precluding successful study participation.Presence of ferromagnetic implants.Presence of a pacemaker or implantable cardioverter-defibrillator (ICD).Renal impairment defined as eGFR <30 mL/min/1.73 m².Known severe allergic reaction to gadolinium-based contrast agents.Current pregnancy or breastfeeding.Any other condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable for the study or interfere with the interpretation of the results.

Design outcomes

Primary

MeasureTime frame
The primary parameter is Ktrans, a DCE-MRI–derived marker of plaque neovascularization.

Secondary

MeasureTime frame
Secondary outcome measures include plaque volume, degree of carotid stenosis, lipid core volume, and other DCE-MRI kinetic parameters

Countries

Netherlands

Contacts

Public ContactM.E. Annink

Amsterdam UMC

m.e.annink@amsterdamumc.nl0630534529

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)