"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"
Recruiting · NCT07427472 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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.
- 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
Where it is running
3 locations listed.
- Plateau d'investigation clinique (PIC) IHU-ICAN - Paris, France
- APHP- Hospital Saint-Antoine - Paris, Île-de-France Region, France
- APHP-Sorbonne, Pitié Salpêtrière Hospital - Paris, Île-de-France Region, France