NCT07427472

Brief Summary

This multicenter, non-randomized interventional study aims to assess coronary artery disease progression over 5 years in patients with genetically confirmed heterozygous familial hypercholesterolemia (HeFH), using coronary computed tomography angiography (CCTA). The primary endpoint is the visual evaluation of coronary stenosis using CAD-RADS v2.0, identifying changes between baseline (2018-2022) and study inclusion. The study will enroll 300 patients (100 protected, 200 non-protected) from La Pitié-Salpêtrière hospital and Saint Antoine Hospital (Paris). Participation lasts up to one week. Total study duration is 2 years, with extended follow-up through routine care data over 10 years.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
121mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Jun 2036

First Submitted

Initial submission to the registry

August 14, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 19, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2028

Expected
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2036

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

August 14, 2025

Last Update Submit

June 22, 2026

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Keywords

Coronary Artery DiseaseAtherosclerosisCoronary Plaque VulnerabilityCardiovascular RiskCardiovascular Events

Outcome Measures

Primary Outcomes (1)

  • Progression of coronary artery disease over 5 years in patients with heterozygous familial hypercholesterolemia

    The evolution of coronary artery disease will be assessed over 5 years in patients with heterozygous familial hypercholesterolemia using coronary CT angiography (CTA). The number of patients with regression, stability, or progression of coronary stenosis will be determined using semi-quantitative visual assessment of coronary stenoses according to the CAD-RADS v2.0 classification, including visual characterization of high-risk plaque features.Time Frame: 5 years Unit of Measure: Number and percentage of participants with regression, stability, or progression of coronary stenosis

    1 day

Secondary Outcomes (38)

  • Change in total coronary plaque volume, lesion type, and proximal aortic calcifications.

    1 day

  • Survival curve of major cardiovascular events incidence.

    1 day

  • Cox regression analysis of cardiovascular event occurrence and associated clinical, biological, and omics data.

    1 day

  • Linear regression of clinical and biological variables by CAD-RADS category change.

    1 day

  • Comparison of omics data by plaque volume change and CAD-RADS category shift.

    1 day

  • +33 more secondary outcomes

Study Arms (1)

Patients with protected and unprotected familial hypercholesterolemia

OTHER

Coronary computed tomography angiography with injection of iodinated contrast material

Other: Coronary computed tomography angiography

Interventions

Coronary computed tomography angiographyOTHER

Coronary computed tomography angiography with injection of iodinated contrast material

Patients with protected and unprotected familial hypercholesterolemia

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with heterozygous familial hypercholesterolemia
  • Aged 30 to 60 years.
  • Patients who underwent a CAC score and a coronary CT angiogram at least 5 years ago, exclusively at the same imaging center (ICT de la Pitié Salpetrière).
  • Patient asymptomatic for exertional chest pain at the time of CCTA
  • Clinical examination performed
  • Beneficiary of a social protection scheme or entitled person (excluding AME)
  • Patient informed and consent form signed

You may not qualify if:

  • Patient under guardianship, or unable to give consent
  • Pregnancy, breast-feeding
  • Technical contraindication: weight \> 250 kg
  • Adults subject to a legal protection order
  • Contraindication to esmolol and/or atenolol
  • Only for patients who need to undergo a CT angiogram and a thoraco-abdominal-pelvic CT scan:
  • Renal insufficiency (LC\<60)
  • Unbalanced diabetes when acquiring a previous coronary angioscanner
  • Personal history of cardiovascular disease and myocardial infarction at the time of CCTA
  • Contraindication to iodinated contrast media
  • Patient having already had an adverse event (AE) during the acquisition of a prior coronary angioscanner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Plateau d'investigation clinique (PIC) IHU-ICAN

Paris, 75013, France

NOT YET RECRUITING

APHP- Hospital Saint-Antoine

Paris, Île-de-France Region, 75013, France

NOT YET RECRUITING

APHP-Sorbonne, Pitié Salpêtrière Hospital

Paris, Île-de-France Region, 75013, France

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Antonio GALLO, MD, PhD

CONTACT

33(0)1 42 17 57 74antonio.gallo@aphp.fr

Franck BOCCARA, MD, PhD

CONTACT

33(0)1 49 28 24 49franck.boccara@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Biology: Specific omic biology (including metabolomics, lipidomics, proteomics, genetics, inflammation, and metagenomics). Imaging: Coronary computed tomography angiography with injection of iodinated contrast material DEXA scan Fibroscan Non-invasive vascular assessment of the fundus using adaptive optics Other: Measurement of arterial stiffness Injection of esmolol or atenolol only for patients with a heart rate \>65 bpm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2025

First Posted

February 23, 2026

Study Start

June 19, 2026

Primary Completion (Estimated)

June 19, 2028

Study Completion (Estimated)

June 19, 2036

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access Criteria
Researchers who provide a methodologically sound proposal

Locations

FR(3)