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"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)" (NCT07427472) | Clinical Trial Compass
Not Applicable
"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)" Plain-language 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.
Who can participate Age range 35 Years – 60 Years
Sex ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓ . Aged between 35 and 60. ✓ . Having undergone CCTA 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 ✕ . Patient under guardianship, or unable to give consent ✕ . Pregnancy, breast-feeding, women of childbearing age in the absence of effective contraception ✕ . Technical contraindication: waist \> 70 cm, weight \> 250 kg ✕ . Renal insufficiency (LC\<60) What they're measuring 1 Progression of coronary artery disease over 5 years in patients with heterozygous familial hypercholesterolemia
Timeframe: 1 day
Trial details NCT ID NCT07427472
Sponsor Assistance Publique - Hôpitaux de Paris
Sponsor type OTHER
Study type INTERVENTIONAL
Primary completion 2027-12-01
Contact for this trial Antonio GALLO, MD, PhD
✕
. Unbalanced diabetes when acquiring coronary angioscanner between 2018 and 2022.
✕ . Personal history of cardiovascular disease and myocardial infarction at the time of CCTA
✕ . Simultaneous participation in other interventional research involving the human body, or period of exclusion following previous research involving the human body still in progress.
✕ . Contraindication to iodinated contrast media