"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patient under guardianship, or unable to give consent
Pregnancy, breast-feeding
Technical contraindication: weight > 250 kg
Simultaneous participation in other interventional research involving the human body, or period of exclusion following previous research involving the human body still in progress.
Trial design
Treatments tested in this trial
- Coronary computed tomography angiography
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov