NCT06601153 Health Improvements by Understanding the Determinants of Residual Risk in Coronary Artery Disease and New Targets for Prevention and Treatment
| NCT ID | NCT06601153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Toscana Gabriele Monasterio |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 961 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2025-10 |
Trial Parameters
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Brief Summary
Current medical treatments, in patients with stable coronary artery disease (CAD), mainly target established risk factors and are able to reduce morbidity and mortality but still leave a substantial residual risk of coronary artery disease progression and events. The main hypothesis of this study is that metabolic derangement, including pre-diabetes, elevated levels of triglycerides, low levels and functionality of high-density lipoprotein cholesterol, often associated with a chronic inflammatory state, is a currently unrecognized and undertreated conditon which could be the most relevant determinant of residual risk. The goal of HURRICANE observational study is to discover specific individual genetic/molecular profiles subtending emerging cardiometabolic and vascular risk patterns and associating with a more severe and progressive coronary artery disease. We will thus develop and preliminary validate new predictive models for the recognition of high-risk patients and explore possible new targets for individualized preventive treatment. The severity, extent and progression of coronary plaques will be assessed by qualitative and quantitative analysis of cardiac computed tomography (CCT) performed in retrospective and prospective cohorts of patients with stable coronary disease.
Eligibility Criteria
RETROSPECTIVE STUDY Inclusion Criteria: * patients with known or suspected stable CAD who underwent CCT for the registered studies "SMARTool" or "Studio di biomarcatori in vivo ed in vitro" * fully accessible CCT image files and whole blood and plasma/serum aliquots stored in BioBank * written informed consent Exclusion Criteria: * overt heart failure (NYHA Class III-IV) and/or reduced systolic LV function (LVEF\<40%) * relevant comorbid conditions limiting expected survival to less than 1 year * CCT exam of suboptimal quality PROSPECTIVE STUDY Inclusion Criteria: * patients with suspected stable CAD clinically referred for a first diagnostic CCT * fully accessible CCT image files and whole blood and plasma/serum aliquots stored in BioBank * written informed consent Exclusion Criteria: * history of previous CAD or major cardiovascular events * overt heart failure (NYHA Class III-IV) and/or reduced systolic LV function (LVEF\<40%) * relevant comorbid conditions limiting ex