Coronary Arterial Disease (CAD)HURRICANENCT06601153
Health Improvements by Understanding the Determinants of Residual Risk in Coronary Artery Disease and New Targets for Prevention and Treatment
An observational study of Coronary Arterial Disease (CAD), run by Fondazione Toscana Gabriele Monasterio at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Cardiac CT
- How many people
- 961 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Jul 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RETROSPECTIVE STUDY From the 684 patients with suspected or known stable CAD, referred to IRCCS SYNLAB SDN in Naples between July 2018 and March 2022 for clinically indicated CCT and enrolled in a previous study (Observational Study 7/18 OSS SDN), 376 patients meeting all eligibility criteria are included in the HURRICANE retrospective study population. From the 263 patients with suspected or known stable CAD, undergoing CCT at FTGM in Pisa from September 2012 to October 2913 and enrolled in a previous study (SMARTool, HORIZON 2020-689068), 185 patients meeting all eligibility criteria complete the HURRICANE retrospective study population. PROSPECTIVE STUDY The population of the prospective longitudinal study will include 400 patients referred at IRCCS SYNLAB SDN in Naples and FTGM in Pisa, over a 12 months period, to a clinically indicated CCT for suspected CAD, meeting all eligibility criteria and signing a written informed consent.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Irccs Synlab Sdn
Naples, 80121
Carlo Cavaliere, MD, +393387484984, carlo.cavaliere@synlab.it
Katia Pane, PhD, +393341363000, katia.pane@synlab.it
- Recruiting
Fondazione Toscana Gabriele Monasterio
Pisa, Italy, 56124
Danilo Neglia, MD, PhD, +393355857594, dneglia@ftgm.it
Alessia Gimelli, MD, +393487831405, alessia.gimelli@ftgm.it
About this study
Official title: Health Improvements by Understanding Residual Risk in CAd and NEw Targets for Prevention/treatment - HURRICANE
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.
Read the detailed description
HURRICANE is an observational clinical study, performed in retrospective and prospective cohorts of patients with stable CAD, to assess the role of emerging cardiometabolic and vascular risk determinants to predict severe and progressive coronary atherosclerosis documented by advanced CCT imaging.
The population of the retrospective study consists of two parallel, independent groups of patients enrolled in previous clinical trials focused on blood and CCT biomarkers of CAD. All participants are assessed for eligibility to the current study which includes in particular availability of blood samples in bio-bank and of interpretable CCT exams. For each cohort and for the whole retrospective population (561 patients) clinical variables (demographic data, cardiovascular risk factors, history of previous CAD, symptoms and medications) and conventional circulating biomarkers (lipid and glucose metabolism, systemic inflammation, liver and kidney function) are recorded. The coronary imaging variables which will provide the disease presence and severity end-points will be derived from qualitative and semiquantitative analyses of CCT exams according to CAD-RADS 2.0 classification system.
The population of the prospective longitudinal study will include 400 patients referred at IRCCS SYNLAB SDN in Naples and FTGM in Pisa, over a 12 months period, to a clinically indicated CCT for suspected CAD, signing a written informed consent and fulfilling Inclusion and exclusion criteria. At baseline, patients will be characterized as in the retrospective study (same clinical variables, conventional circulating biomarkers and CCT imaging variables) and blood samples will be collected and stored in the dedicated Bio-Bank for advanced genetic/molecular analyses. They will be submitted to monitoring visits and a last follow-up visit at 12 months when compliance to medical treatment and events will be registered. A second blood sample will be collected and stored in dedicated Bio-Bank for advanced molecular analyses. A second CCT scan will be performed at 12 months with the same scanner, at the same institution, by the use of a state-of-the art CCT technology with high spatial and temporal resolution to provide quantitative measurements of coronary plaque volumes and coronary plaque composition which will be used to define the disease progression end-points.
Qualitative and semiquantitative analyses of CCT exams will be performed by radiologists according to CAD-RADS 2.0 classification systemin both the retrospective and prospective populations. In the prospective population, CCT images at enrollment and follow-up will also be quantitatively analyzed to define evolving CAD phenotypes. Quantitative analysis will be performed on visually identified plaques using a dedicated software package (QAngio CT Research Edition version 3.1.2.0, Medis Medical Imaging Systems, Leiden, the Netherlands) to generate detailed output on the lumen and plaque statistics, including the degree of stenosis, lesion length, vessel volume, plaque burden, plaque volume, and plaque components (according to the virtual histology classification: dense calcium, necrotic core, fibrous-fatty, fibrous, and media). Additional CT-derived parameters will also be assessed, in particular epicardial and perivascular adipose tissue, to be tested in the predictive models of CAD evolution and to be entered in a Machine Learning data analysis as potential variables of the pathophysiologic CAD network.
Circulating biomarkers will be evaluated by standard methodologies of clinical chemistry laboratories at the two participant clinical centers and specific circulating biomarkers will be analyzed at the IFC-CNR Core-Lab in both the retrospective and the prospective populations. In particular, additional markers of lipid metabolism and adipose tissue function, endothelial function and atherosclerotic burden will be evaluated by dedicated immunoassays, while markers of myocardial damage/function will be evaluated by automatized immunoassays. The inflammatory profile will be assessed by multiplex cytokine screens."Omics" analyses, in both populations, will include lipidomic, with the assessment of circulating lipid species using mass spectrometry, and genetic profiling by GWAS (Genome-Wide Association Study) performed by an external provider (Genomix4Life) using new generation microarray technology to genotype single-nucleotide variants (SNVs). In representative extreme groups of patients from the prospective population, a specific panel of 88 candidate genes involved in lipid/glucose homeostasis, endothelial/vascular function and systemic inflammation, together with other relevant genes emerging from the GWAS analysis, will be sequenced for known and unknown variants at FTGM by NGS (Next Generation Sequencing) approach. The library preparation for NGS will be performed using the Illumina DNA Prep with Enrichment Kit. Base-Space Variant Interpreter software will be used to annotate, filter and interpret the variants. The degree of pathogenicity will be also assessed on VarSome (https://varsome.com) and GWAS Catalog (https://www.ebi.ac.uk/gwas/), search engines and impact analysis tools for human genetic variation. The variants identified as pathogenetically relevant, in the subjects with extreme phenotypes will then be assessed in the rest of the population. Moreover, miRNAs, putatively associated with relevant gene variants and screened by in silico bioinformatic analysis, will be assessed by qPCR.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Cardiac CT
- Keywords
- coronary artery disease (CAD); cardiac CT (CCT); cardiovascular risk factors; atherogenic dyslipidemia; insulin resistance (IR); molecular medicine; genetics.
- Medical subject headings
- Coronary Artery Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTDiagnostic test
Also called Computed Tomography Coronary Angiography
Cardiac CT to characterize coronary atherosclerosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cardiac CT | |
| 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. Receives: Diagnostic Test: Cardiac CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
The primary objective is the development (retrospective study) and validation (prospective study) of new integrated clinical and molecular/genetic predictive models of severity and extent of CAD defined by CCT in patients with stable disease. Developed models will be extended (prospective study) to the prediction of progression (at 1-year follow-up) of CAD phenotypes occurring despite OMT. The hypothesis is that these models, including specific molecular markers (assessed by traditional laboratory as well as by "omics" approaches) of emerging cardiometabolic and vascular risk, could predict CAD severity/extent and progression more accurately than other traditional risk models.
Measured: In the prospective Study patients will be evaluated at baseline and follow-up within a18 months time frame.
Secondary outcomes (1)
Secondary Objective
The secondary objective is to perform a pathophysiologic sub study in selected groups of patients, from the prospective population, with extreme cardiometabolic and coronary disease phenotypes. The hypothesis is that a specific characterization, focused on relevant molecules and genes involved in lipid/glucose homeostasis, endothelial/vascular function and chronic low-grade systemic inflammation, in selected groups of patients with/without clinically defined patterns of high cardiometabolic/vascular risk and with/without CCT defined phenotypes of high CAD risk may unveil pathophysiological associations yet unrecognized because diluted by multiple other confounding variables in the modelling approach performed in non-selected populations.
Measured: In the prospective Study selected groups of patients will be evaluated at baseline and follow-up within a18 months time frame.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Jul 2023
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 961 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Toscana Gabriele Monasterio
- Sponsor type
- University, hospital or other
- Collaborators
- CNR Institute of Clinical Physiology, Pisa, Italy, IRCCS SYNLAB SDN, Naples, Italy
- Responsible party
- Principal investigator, Danilo Neglia, Fondazione Toscana Gabriele Monasterio
- Investigators
- Danilo Neglia, MD, PhD, Study chair, Fondazione Toscana Gabriele Monasterio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601153
- Sponsor's protocol ID
- PNRR-MAD-2022-12376550
- Acronym
- HURRICANE
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing will be evaluated and decided together with the Institutions involved and in agreement with the rules of the competent Ethics Committees and of Italian Ministry of Health for PNRR funded prjects
Publications
Cademartiri F, Meloni A, Pistoia L, Degiorgi G, Clemente A, Gori C, Positano V, Celi S, Berti S, Emdin M, Panetta D, Menichetti L, Punzo B, Cavaliere C, Bossone E, Saba L, Cau R, Grutta L, Maffei E. Dual-Source Photon-Counting Computed Tomography-Part I: Clinical Overview of Cardiac CT and Coronary CT Angiography Applications. J Clin Med. 2023 May 23;12(11):3627. doi: 10.3390/jcm12113627.
PubMed 37297822Neglia D, Liga R, Gimelli A, Podlesnikar T, Cvijic M, Pontone G, Miglioranza MH, Guaricci AI, Seitun S, Clemente A, Sumin A, Vitola J, Saraste A, Paunonen C, Sia CH, Paleev F, Sade LE, Zamorano JL, Maroz-Vadalazhskaya N, Anagnostopoulos C, Macedo F, Knuuti J, Edvardsen T, Cosyns B, Petersen SE, Magne J, Laroche C, Berle C, Popescu BA, Delgado V; EURECA Investigators. Use of cardiac imaging in chronic coronary syndromes: the EURECA Imaging registry. Eur Heart J. 2023 Jan 7;44(2):142-158. doi: 10.1093/eurheartj/ehac640.
PubMed 36452988Neglia D, Caselli C, Maffei E, Cademartiri F, Meloni A, Bossone E, Saba L, Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Marques H, de Araujo Goncalves P, Pontone G, Shin S, Stone PH, Samady H, Virmani R, Narula J, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Rapid Plaque Progression Is Independently Associated With Hyperglycemia and Low HDL Cholesterol in Patients With Stable Coronary Artery Disease: A PARADIGM Study. Circ Cardiovasc Imaging. 2024 Jul;17(7):e016481. doi: 10.1161/CIRCIMAGING.123.016481. Epub 2024 Jul 16.
PubMed 39012946Caselli C, De Caterina R, Smit JM, Campolo J, El Mahdiui M, Ragusa R, Clemente A, Sampietro T, Clerico A, Liga R, Pelosi G, Rocchiccioli S, Parodi O, Scholte A, Knuuti J, Neglia D; EVINCI and SMARTool. Triglycerides and low HDL cholesterol predict coronary heart disease risk in patients with stable angina. Sci Rep. 2021 Oct 20;11(1):20714. doi: 10.1038/s41598-021-00020-3.
PubMed 34671067Neglia D, Aimo A, Lorenzoni V, Caselli C, Gimelli A. Triglyceride-glucose index predicts outcome in patients with chronic coronary syndrome independently of other risk factors and myocardial ischaemia. Eur Heart J Open. 2021 Jul 24;1(1):oeab004. doi: 10.1093/ehjopen/oeab004. eCollection 2021 Aug.
PubMed 35919094Di Giorgi N, Michelucci E, Smit JM, Scholte AJHA, El Mahdiui M, Knuuti J, Buechel RR, Teresinska A, Pizzi MN, Roque A, Poddighe R, Parodi O, Pelosi G, Caselli C, Neglia D, Rocchiccioli S. A specific plasma lipid signature associated with high triglycerides and low HDL cholesterol identifies residual CAD risk in patients with chronic coronary syndrome. Atherosclerosis. 2021 Dec;339:1-11. doi: 10.1016/j.atherosclerosis.2021.11.013. Epub 2021 Nov 11.
PubMed 34801858Caselli C, Occhipinti M, Pane K, De Gori C, Rocchiccioli S, Botto N, Prontera C, Cavaliere C, Ragusa R, Vecoli C, Sansone F, Passaro E, Ceccherini E, Morlando A, Clemente A, Franzese M, Maffei E, Punzo B, Gimelli A, Cademartiri F, Neglia D. Health improvements by understanding residual risk in coronary artery disease and new targets for prevention/treatment: rationale and research protocol of the HURRICANE project. Eur Heart J Open. 2025 Jan 28;5(1):oeaf005. doi: 10.1093/ehjopen/oeaf005. eCollection 2025 Jan.
PubMed 39949422
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Improvements by Understanding Residual Risk in CAd and NEw Targets for Prevention/treatment - HURRICANE
- ClinicalTrials.gov ID
- NCT06601153
- Acronym / sponsor ID
- HURRICANE / PNRR-MAD-2022-12376550
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- coronary artery disease (CAD); cardiac CT (CCT); cardiovascular risk factors; atherogenic dyslipidemia; insulin resistance (IR); molecular medicine; genetics.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 961 participants (estimated)
- Lead sponsor
- Fondazione Toscana Gabriele MonasterioUniversity, hospital or other
- Collaborators
- CNR Institute of Clinical Physiology, Pisa, Italy, IRCCS SYNLAB SDN, Naples, Italy
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HURRICANE is an observational clinical study, performed in retrospective and prospective cohorts of patients with stable CAD, to assess the role of emerging cardiometabolic and vascular risk determinants to predict severe and progressive coronary atherosclerosis documented by advanced CCT imaging.
The population of the retrospective study consists of two parallel, independent groups of patients enrolled in previous clinical trials focused on blood and CCT biomarkers of CAD. All participants are assessed for eligibility to the current study which includes in particular availability of blood samples in bio-bank and of interpretable CCT exams. For each cohort and for the whole retrospective population (561 patients) clinical variables (demographic data, cardiovascular risk factors, history of previous CAD, symptoms and medications) and conventional circulating biomarkers (lipid and glucose metabolism, systemic inflammation, liver and kidney function) are recorded. The coronary imaging variables which will provide the disease presence and severity end-points will be derived from qualitative and semiquantitative analyses of CCT exams according to CAD-RADS 2.0 classification system.
The population of the prospective longitudinal study will include 400 patients referred at IRCCS SYNLAB SDN in Naples and FTGM in Pisa, over a 12 months period, to a clinically indicated CCT for suspected CAD, signing a written informed consent and fulfilling Inclusion and exclusion criteria. At baseline, patients will be characterized as in the retrospective study (same clinical variables, conventional circulating biomarkers and CCT imaging variables) and blood samples will be collected and stored in the dedicated Bio-Bank for advanced genetic/molecular analyses. They will be submitted to monitoring visits and a last follow-up visit at 12 months when compliance to medical treatment and events will be registered. A second blood sample will be collected and stored in dedicated Bio-Bank for advanced molecular analyses. A second CCT scan will be performed at 12 months with the same scanner, at the same institution, by the use of a state-of-the art CCT technology with high spatial and temporal resolution to provide quantitative measurements of coronary plaque volumes and coronary plaque composition which will be used to define the disease progression end-points.
Qualitative and semiquantitative analyses of CCT exams will be performed by radiologists according to CAD-RADS 2.0 classification systemin both the retrospective and prospective populations. In the prospective population, CCT images at enrollment and follow-up will also be quantitatively analyzed to define evolving CAD phenotypes. Quantitative analysis will be performed on visually identified plaques using a dedicated software package (QAngio CT Research Edition version 3.1.2.0, Medis Medical Imaging Systems, Leiden, the Netherlands) to generate detailed output on the lumen and plaque statistics, including the degree of stenosis, lesion length, vessel volume, plaque burden, plaque volume, and plaque components (according to the virtual histology classification: dense calcium, necrotic core, fibrous-fatty, fibrous, and media). Additional CT-derived parameters will also be assessed, in particular epicardial and perivascular adipose tissue, to be tested in the predictive models of CAD evolution and to be entered in a Machine Learning data analysis as potential variables of the pathophysiologic CAD network.
Circulating biomarkers will be evaluated by standard methodologies of clinical chemistry laboratories at the two participant clinical centers and specific circulating biomarkers will be analyzed at the IFC-CNR Core-Lab in both the retrospective and the prospective populations. In particular, additional markers of lipid metabolism and adipose tissue function, endothelial function and atherosclerotic burden will be evaluated by dedicated immunoassays, while markers of myocardial damage/function will be evaluated by automatized immunoassays. The inflammatory profile will be assessed by multiplex cytokine screens."Omics" analyses, in both populations, will include lipidomic, with the assessment of circulating lipid species using mass spectrometry, and genetic profiling by GWAS (Genome-Wide Association Study) performed by an external provider (Genomix4Life) using new generation microarray technology to genotype single-nucleotide variants (SNVs). In representative extreme groups of patients from the prospective population, a specific panel of 88 candidate genes involved in lipid/glucose homeostasis, endothelial/vascular function and systemic inflammation, together with other relevant genes emerging from the GWAS analysis, will be sequenced for known and unknown variants at FTGM by NGS (Next Generation Sequencing) approach. The library preparation for NGS will be performed using the Illumina DNA Prep with Enrichment Kit. Base-Space Variant Interpreter software will be used to annotate, filter and interpret the variants. The degree of pathogenicity will be also assessed on VarSome (https://varsome.com) and GWAS Catalog (https://www.ebi.ac.uk/gwas/), search engines and impact analysis tools for human genetic variation. The variants identified as pathogenetically relevant, in the subjects with extreme phenotypes will then be assessed in the rest of the population. Moreover, miRNAs, putatively associated with relevant gene variants and screened by in silico bioinformatic analysis, will be assessed by qPCR.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort of 561 patients with suspected CAD | – | Diagnostic Test: Cardiac CTAll 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 | – | Diagnostic Test: Cardiac CTAll 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RETROSPECTIVE STUDY From the 684 patients with suspected or known stable CAD, referred to IRCCS SYNLAB SDN in Naples between July 2018 and March 2022 for clinically indicated CCT and enrolled in a previous study (Observational Study 7/18 OSS SDN), 376 patients meeting all eligibility criteria are included in the HURRICANE retrospective study population. From the 263 patients with suspected or known stable CAD, undergoing CCT at FTGM in Pisa from September 2012 to October 2913 and enrolled in a previous study (SMARTool, HORIZON 2020-689068), 185 patients meeting all eligibility criteria complete the HURRICANE retrospective study population. PROSPECTIVE STUDY The population of the prospective longitudinal study will include 400 patients referred at IRCCS SYNLAB SDN in Naples and FTGM in Pisa, over a 12 months period, to a clinically indicated CCT for suspected CAD, meeting all eligibility criteria and signing a written informed consent.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CTAlso: Computed Tomography Coronary AngiographyCardiac CT to characterize coronary atherosclerosis | Diagnostic test | Prospective cohort od 400 patients with suspected CAD, Retrospective cohort of 561 patients with suspected CAD |
Primary outcome
Primary Objective
Time frame: In the prospective Study patients will be evaluated at baseline and follow-up within a18 months time frame.
The primary objective is the development (retrospective study) and validation (prospective study) of new integrated clinical and molecular/genetic predictive models of severity and extent of CAD defined by CCT in patients with stable disease. Developed models will be extended (prospective study) to the prediction of progression (at 1-year follow-up) of CAD phenotypes occurring despite OMT. The hypothesis is that these models, including specific molecular markers (assessed by traditional laboratory as well as by "omics" approaches) of emerging cardiometabolic and vascular risk, could predict CAD severity/extent and progression more accurately than other traditional risk models.
1 secondary outcome
Secondary Objective
Time frame: In the prospective Study selected groups of patients will be evaluated at baseline and follow-up within a18 months time frame.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 37297822Cademartiri F, Meloni A, Pistoia L, Degiorgi G, Clemente A, Gori C, Positano V, Celi S, Berti S, Emdin M, Panetta D, Menichetti L, Punzo B, Cavaliere C, Bossone E, Saba L, Cau R, Grutta L, Maffei E. Dual-Source Photon-Counting Computed Tomography-Part I: Clinical Overview of Cardiac CT and Coronary CT Angiography Applications. J Clin Med. 2023 May 23;12(11):3627. doi: 10.3390/jcm12113627.
- Background: PubMed 36452988Neglia D, Liga R, Gimelli A, Podlesnikar T, Cvijic M, Pontone G, Miglioranza MH, Guaricci AI, Seitun S, Clemente A, Sumin A, Vitola J, Saraste A, Paunonen C, Sia CH, Paleev F, Sade LE, Zamorano JL, Maroz-Vadalazhskaya N, Anagnostopoulos C, Macedo F, Knuuti J, Edvardsen T, Cosyns B, Petersen SE, Magne J, Laroche C, Berle C, Popescu BA, Delgado V; EURECA Investigators. Use of cardiac imaging in chronic coronary syndromes: the EURECA Imaging registry. Eur Heart J. 2023 Jan 7;44(2):142-158. doi: 10.1093/eurheartj/ehac640.
- Background: PubMed 39012946Neglia D, Caselli C, Maffei E, Cademartiri F, Meloni A, Bossone E, Saba L, Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Marques H, de Araujo Goncalves P, Pontone G, Shin S, Stone PH, Samady H, Virmani R, Narula J, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Rapid Plaque Progression Is Independently Associated With Hyperglycemia and Low HDL Cholesterol in Patients With Stable Coronary Artery Disease: A PARADIGM Study. Circ Cardiovasc Imaging. 2024 Jul;17(7):e016481. doi: 10.1161/CIRCIMAGING.123.016481. Epub 2024 Jul 16.
- Background: PubMed 34671067Caselli C, De Caterina R, Smit JM, Campolo J, El Mahdiui M, Ragusa R, Clemente A, Sampietro T, Clerico A, Liga R, Pelosi G, Rocchiccioli S, Parodi O, Scholte A, Knuuti J, Neglia D; EVINCI and SMARTool. Triglycerides and low HDL cholesterol predict coronary heart disease risk in patients with stable angina. Sci Rep. 2021 Oct 20;11(1):20714. doi: 10.1038/s41598-021-00020-3.
- Background: PubMed 35919094Neglia D, Aimo A, Lorenzoni V, Caselli C, Gimelli A. Triglyceride-glucose index predicts outcome in patients with chronic coronary syndrome independently of other risk factors and myocardial ischaemia. Eur Heart J Open. 2021 Jul 24;1(1):oeab004. doi: 10.1093/ehjopen/oeab004. eCollection 2021 Aug.
- Background: PubMed 34801858Di Giorgi N, Michelucci E, Smit JM, Scholte AJHA, El Mahdiui M, Knuuti J, Buechel RR, Teresinska A, Pizzi MN, Roque A, Poddighe R, Parodi O, Pelosi G, Caselli C, Neglia D, Rocchiccioli S. A specific plasma lipid signature associated with high triglycerides and low HDL cholesterol identifies residual CAD risk in patients with chronic coronary syndrome. Atherosclerosis. 2021 Dec;339:1-11. doi: 10.1016/j.atherosclerosis.2021.11.013. Epub 2021 Nov 11.
- Derived from this study: PubMed 39949422Caselli C, Occhipinti M, Pane K, De Gori C, Rocchiccioli S, Botto N, Prontera C, Cavaliere C, Ragusa R, Vecoli C, Sansone F, Passaro E, Ceccherini E, Morlando A, Clemente A, Franzese M, Maffei E, Punzo B, Gimelli A, Cademartiri F, Neglia D. Health improvements by understanding residual risk in coronary artery disease and new targets for prevention/treatment: rationale and research protocol of the HURRICANE project. Eur Heart J Open. 2025 Jan 28;5(1):oeaf005. doi: 10.1093/ehjopen/oeaf005. eCollection 2025 Jan.
- Individual participant dataSharing planned: Undecided. IPD sharing will be evaluated and decided together with the Institutions involved and in agreement with the rules of the competent Ethics Committees and of Italian Ministry of Health for PNRR funded prjects
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danilo Neglia, MD, PhD study chair
Fondazione Toscana Gabriele Monasterio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD), run by Fondazione Toscana Gabriele Monasterio at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danilo Neglia, MD, PhD (+393355857594, dneglia@ftgm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: In the prospective Study patients will be evaluated at baseline and follow-up within a18 months time frame.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06601153, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.