Understanding risk factors in coronary artery disease for better prevention and treatment
Health Improvements by Understanding Residual Risk in CAd and NEw Targets for Prevention/treatment - HURRICANE
This study is trying to find out what genetic and health factors make coronary artery disease worse so that doctors can better prevent and treat it in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 961 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione Toscana Gabriele Monasterio Academic / other |
| Locations | 2 sites (Pisa, Italy and 1 other locations) |
| Trial ID | NCT06601153 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify genetic and molecular profiles that contribute to the progression of coronary artery disease (CAD) by examining both retrospective and prospective cohorts of patients with stable CAD. It will analyze clinical variables, circulating biomarkers, and advanced cardiac CT imaging to develop predictive models for recognizing high-risk patients. The study focuses on metabolic derangements and inflammation as potential unrecognized determinants of residual risk in CAD. By leveraging existing data and new patient assessments, the study seeks to enhance understanding of CAD progression and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include patients with known or suspected stable coronary artery disease who are undergoing cardiac CT imaging.
Not a fit: Patients with overt heart failure or significant comorbid conditions limiting survival may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective prevention and treatment strategies for patients with coronary artery disease.
How similar studies have performed: Other studies have explored similar approaches, but this study aims to validate new predictive models, making it a novel contribution to the field.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pisa, Italy and 1 other locations
- Fondazione Toscana Gabriele Monasterio — Pisa, Italy, Italy (Recruiting)
- Irccs Synlab Sdn — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Danilo Neglia, MD, PhD
- Email: dneglia@ftgm.it
- Phone: +393355857594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.