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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 961 participants in total. It began in 2023-07-07 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 expected survival to less than 1 year * CCT exam of suboptimal quality
Contact & Investigator
Danilo Neglia, MD, PhD
STUDY CHAIR
Fondazione Toscana Gabriele Monasterio
Frequently Asked Questions
Who can join the NCT06601153 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06601153 currently recruiting?
Yes, NCT06601153 is actively recruiting participants. Contact the research team at dneglia@ftgm.it for enrollment information.
Where is the NCT06601153 trial being conducted?
This trial is being conducted at Pisa, Italy, Naples, Italy.
Who is sponsoring the NCT06601153 clinical trial?
NCT06601153 is sponsored by Fondazione Toscana Gabriele Monasterio. The principal investigator is Danilo Neglia, MD, PhD at Fondazione Toscana Gabriele Monasterio. The trial plans to enroll 961 participants.