Actively Recruiting

Age: 40Years - 75Years
All Genders
NCT06601153

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

Led by Fondazione Toscana Gabriele Monasterio · Updated on 2024-09-19

961

Participants Needed

2

Research Sites

125 weeks

Total Duration

On this page

Sponsors

F

Fondazione Toscana Gabriele Monasterio

Lead Sponsor

C

CNR Institute of Clinical Physiology, Pisa, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 40 to 75 years
  • Patients with known or suspected stable coronary artery disease (CAD) who underwent cardiac CT (CCT) in previous studies or are clinically referred for a first diagnostic CCT
  • Fully accessible CCT image files and blood samples stored in a biobank
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Overt heart failure classified as NYHA Class III or IV and/or reduced left ventricular ejection fraction below 40%
  • Serious comorbid conditions limiting expected survival to less than one year
  • Cardiac CT exam of suboptimal quality
  • History of previous coronary artery disease or major cardiovascular events (for prospective study participants)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Fondazione Toscana Gabriele Monasterio

Pisa, Italy, Italy, 56124

Actively Recruiting

2

Irccs Synlab Sdn

Naples, Italy, 80121

Actively Recruiting

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Research Team

D

Danilo Neglia, MD, PhD

CONTACT

M

Maria Sole Morelli, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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