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Actively Recruiting

Phase Not Applicable
Age: 30Years - 60Years
All Genders
ID07427472

Tracking Coronary Artery Disease Progression Using CT Angiography in Adults with Heterozygous Familial Hypercholesterolemia Over 5 Years

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-06-24

300

Participants Needed

3

Research Sites

417 weeks

Total Duration

AI-Summary

What this Trial Is About

This multicenter interventional study evaluates the progression of coronary artery disease over 5 years in adults aged 30 to 60 years with genetically confirmed heterozygous familial hypercholesterolemia HeFH. The study addresses challenges in cardiovascular risk assessment for HeFH patients, focusing on both calcified and non-calcified plaques using advanced imaging techniques. It aims to better understand plaque burden changes and classify coronary stenosis using the CAD-RADS v2.0 system, comparing baseline data from 2018-2022 with current findings. Participants undergo coronary computed tomography angiography CCTA with iodinated contrast to visualize coronary arteries. The study includes 300 patients divided into protected and non-protected groups based on their clinical characteristics. Individual participation lasts from one day up to one week, with the overall study period spanning 2 years. Extended follow-up for up to 10 years will use routinely collected medical data to monitor cardiovascular events and disease progression. During the study visit, participants receive detailed imaging assessments, clinical exams, and questionnaires measuring health status and cardiovascular risk factors. Researchers measure coronary plaque volume, lesion types, calcium scores, arterial dimensions, and other biomarkers. They also evaluate quality of life and symptoms using validated surveys. Safety and cardiovascular events are tracked through long-term medical record review. This comprehensive evaluation helps identify changes in coronary artery disease and related health outcomes over time.

CONDITIONS

Brief Title

"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"

Research Team

A

Antonio GALLO, MD, PhD

F

Franck BOCCARA, MD, PhD

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