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VISION-FH

Vascular Imaging of Atherosclerotic Plaque Progression in Familial Hypercholesterolemia - VISION-FH

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON61449
Enrollment
177
Registered
2026-04-08
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Familial Hypercholesterolemia Inherited high cholesterol

Interventions

CT-scan of coronaries and carotids using photon-counting CT.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of heterozygous FH, either genetically confirmed or a Dutch Lipid Clinic Network (DLCN) score of = 6Age between 55 - 80 years

Exclusion criteria

Exclusion criteria: Homozygous FHeGFR <45 ml/min/1.73m2 BMI > 35 kg/m2Previous Coronary Artery Bypass Graft (CABG) Previous Stent in 2 or more coronary arteries Previous Carotid Endarterectomy (CEA)Allergy to iodinated contrast material Concomitant or previous participation in a study that prohibits the patient from participating in a study that exposes the patient to radiation Concomitant participation in a study that may influence the progression or characteristics of atherosclerotic plaqueInability to provide informed consentLife expectancy < 18 months

Design outcomes

Primary

MeasureTime frame
The assessment of coronary atherosclerotic disease burden, measured as coronary TPV, and its progression over time in FH patients. This will be measured across different vessels at two CT-scans with 18 months in between. 

Secondary

MeasureTime frame
The determinants that might influence variability of atherosclerotic plaque burden will be measured, in both coronary and carotid arteries at baseline and follow-up. The following determinants will be evaluated:Stenosis percentageQualitative plaque composition and its volumes per componen Coronary Artery Calcium score (CAC)FAIChange of determinants over time will be assessed using the 18 months follow-up scan. TPV in the carotid arteries will also be assessed using the same method as for the primary endpoint.Patients will also be divided in different categories depending on their baseline CT-scan, based on plaque and inflattion parameters.Immune status and inflammation will be analysed. This will be done through analysis of biomarkers in the blood such as PBMC and proteomics. Genetics will also be analysed in order to identify DNA-segments which are more prone to plaque progression.

Countries

Netherlands

Contacts

Public ContactK.O. Adriaansens

Erasmus MC, Universitair Medisch Centrum Rotterdam

vasculaire.genetica@erasmusmc.nl0107030420

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026