RecruitingNCT06601153

Health Improvements by Understanding the Determinants of Residual Risk in Coronary Artery Disease and New Targets for Prevention and Treatment

Health Improvements by Understanding Residual Risk in CAd and NEw Targets for Prevention/treatment - HURRICANE


Sponsor

Fondazione Toscana Gabriele Monasterio

Enrollment

961 participants

Start Date

Jul 7, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria7

  • RETROSPECTIVE STUDY
  • 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
  • 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 Criteria8

  • 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
  • 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

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Interventions

DIAGNOSTIC_TESTCardiac CT

Cardiac CT to characterize coronary atherosclerosis


Locations(2)

Fondazione Toscana Gabriele Monasterio

Pisa, Italy, Italy

Irccs Synlab Sdn

Naples, Italy

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NCT06601153


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