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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Irccs Synlab Sdn
RECRUITING
Napoli
Fondazione Toscana Gabriele Monasterio
RECRUITING
Pisa
Contact Information
Primary
Danilo Neglia, MD, PhD
dneglia@ftgm.it
+393355857594
Backup
Maria Sole Morelli, PhD
msmorelli@ftgm.it
+393498337562
Time Frame
Start Date: 2023-07-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 961
Treatments
Retrospective cohort of 561 patients with suspected CAD
All patients with suspected CAD with available blood samples stored in bio-banks and interpretable CCT stored in imaging repositories.
Prospective cohort od 400 patients with suspected CAD
All patients with suspected CAD in whom with blood samples will be collected and stored in bio-banks and CCT will be acquired and stored in imaging repositories.
Related Therapeutic Areas
Sponsors
Collaborators: IRCCS SYNLAB SDN, Naples, Italy, CNR Institute of Clinical Physiology, Pisa, Italy
Leads: Fondazione Toscana Gabriele Monasterio

This content was sourced from clinicaltrials.gov