"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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Coronary computed tomography angiography
Other interventionCoronary computed tomography angiography with injection of iodinated contrast material
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients with protected and unprotected familial hypercholesterolemiaOther 1 intervention
Trial outcomes
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
Time frame
1 daySecondary outcomes
1
Change in total coronary plaque volume, lesion type, and proximal aortic calcifications.
Assessment of coronary artery disease progression in HeFH patients using 5-years follow-up CCTA. CAD-RADS v2.0 will be used to evaluate changes in stenosis severity and identify high-risk plaques. Progression will be defined by a change in CAD-RADS category between first CCTA (defined as baseline, realized between 2018 and 2022) and inclusion in DESTINY-FH
Time frame
1 day2
Survival curve of major cardiovascular events incidence.
Incidence of myocardial infarction, ischemic stroke, transient ischemic attack, and coronary, carotid, and/or femoral revascularization since baseline CCTA in both groups
Time frame
1 day3
Cox regression analysis of cardiovascular event occurrence and associated clinical, biological, and omics data.
Evaluation of the association between cardiovascular event occurrence (as defined in outcome 2) and clinical, biological, omics, and macro/microvascular data using Cox regression analysis.
Time frame
1 day4
Linear regression of clinical and biological variables by CAD-RADS category change.
Comparison and linear regression of clinical and biological explanatory variables according to change in CAD-RADS category between baseline and inclusion, in the overall cohort and stratified by groups.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov