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Detection and Longitudinal Follow-up of Non-calcified and Calcified Coronary Lesions in Heterozygous Familial Hypercholesterolemia (DESTINY-FH)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
APHP- Hospital Saint-Antoine
NOT_YET_RECRUITING
Paris
APHP-Sorbonne, Pitié Salpêtrière Hospital
RECRUITING
Paris
Plateau d'investigation clinique (PIC) IHU-ICAN
NOT_YET_RECRUITING
Paris
Contact Information
Primary
Antonio GALLO, MD, PhD
antonio.gallo@aphp.fr
33(0)1 42 17 57 74
Backup
Franck BOCCARA, MD, PhD
franck.boccara@aphp.fr
33(0)1 49 28 24 49
Time Frame
Start Date: 2026-06-19
Estimated Completion Date: 2036-06-19
Participants
Target number of participants: 300
Treatments
Other: Patients with protected and unprotected familial hypercholesterolemia
Coronary computed tomography angiography with injection of iodinated contrast material
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov