"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"

NCT04448691 | Completed DMC

• 1 other identifier: 23534
• Study Type: interventional
• Target: 275
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coronary atherosclerosis (ATS) is a degenerative-inflammatory artery pathology underlying the different clinical manifestations of coronary heart disease (CHD), from stable angina due to constrictive plaque growth obstructing artery lumen, to acute coronary syndrome (ACS), secondary to abrupt lumen occlusion by atherothrombosis at the site of a ruptured or eroded plaque. Major coronary adverse events (MACE) are known to be related to local factors, the so called "high risk plaque" characterized by large lipid-necrotic core with a thin fibrous cap, intraplaque hemorrhage, rupture, erosion, and to systemic, patient-specific, factors, contributing to the atherogenic genotype/phenotype of the so called "high risk patient", presenting with an abnormally activated thrombogenic and/or inflammatory state or increased plasma levels of atherogenic lipid species. The huge social and economic impact of CHD in western and developing countries is primarily due to the difficulty to identify and predict, in the clinical context, which "high risk plaque" in which "high risk patient" will cause, independently of stenosis severity, an acute coronary event such as myocardial infarction or sudden coronary death, which are often the first manifestations of CHD in a large proportion of otherwise asymptomatic subjects. Plaque burden, compared to stenosis, is recognized as a better predictor of ACS and coronary CT angiography (CCTA) is considered as the optimal non-invasive coronary imaging modality to assess and quantify plaque burden and to evaluate the functional significance of a stenosis, by computationally estimating fractional flow reserve. Moreover, molecular studies of CHD patients have mostly examined associations with clinical cardiovascular outcomes: associations with coronary ATS assessed by quantitative CCTA may provide insight into the pathophysiological role of several molecular species in plaque formation and growth, and elucidate their potential role as discriminative biomarkers of CHD. Based on these considerations, aim of this study is to collect and analyze all patient-specific clinical and epidemiological data and patient phenotype and genotype blood-derived molecular information, and to combine them with local high resolution non-invasive CCTA imaging of actual plaque burden as well as, prospectively, of its increase or de novo formation over a clinically relevant timespan. The expected result, following local and systemic data integration and modeling, is to optimize early diagnosis and risk stratification of CHD beyond current clinical models and scores and to help improving primary and secondary prevention of MACE. The overall design of this diagnostic and prognostic framework has been proposed to Horizon 2020 EU Call PHC30 and approved by the European Commission (Grant Agreement PHC30-689068). The Consortium includes major clinical European University Hospitals specialized in CHD imaging and treatment and the project study has obtained the endorsement of the European Society of Cardiovascular Imaging.

Conditions

Management/Treatment of Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• coronary artery disease progression assessed by CCTA

  6 years CCTA follow up

Study Arms (1)

CCTA

OTHER

Suspected coronary disease patients enrolled in EVINCI trial with CCTA where recalled for follow up CCTA and blood sampling

Diagnostic Test: CCTA

Interventions

CCTA DIAGNOSTIC_TEST

requested follow up CCTA

CCTA

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female subjects
• aged 45-75 years
• caucasian population
• submitted to CCTA for suspected CHD between 2009 and 2012 (in the context of EVINCI and ARTreat FPVII studies) at the Hospitals reported in "SMARTool Clinical Center" document and satisfying the elegibility criteria reported above
• submitted to clinical Follow-up in the last 6 months with stable clinical conditions and documented CHD or persistent intermediate/high probability of CHD
• Signed informed consents (clinical and genetic)

You may not qualify if:

• Multi-vessel severe disease (3 vessels and/or LM disease with \>90% stenosis).
• Severe coronary calcification (CAC score \> 600).
• Having undergone surgical procedures related to heart diseases (CABG, valve replacement, CRT or CRTD treatment, any surgery of the heart or arteries).
• Documented MACE at history (myocardial infarction, severe heart failure, recurrent angina) in the last 6 months with/without revascularization
• Documented severe peripheral vascular disease (carotid, femoral)
• Surgery of carotid and/or peripheral arteries or cerebral ischemic attack
• History/surgery of Abdominal Aortic Aneurysm(AAA).
• Severe Heart failure (NYHA Class III-IV)
• LV dysfunction (left ventricle EF \<40%).
• Atrial fibrillation.
• Lack of written informed consent (clinical consent and/or genetic consent)
• Pregnancy (evaluated by urine test) and breastfeeding
• Active Cancer
• Asthma
• Severe untreated Hypertension (arterial blood pressure ≥ 170/110 mmHg)

Sponsors & Collaborators

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: lead
• University of Zurich: collaborator
• Turku University Hospital: collaborator
• Azienda USL 12 Versilia: collaborator
• Federico II University: collaborator
• Institut Catala de Salut: collaborator
• National Institute of Cardiology, Warsaw, Poland: collaborator

Related Publications (3)

• Caselli 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.

  PMID: 34671067 DERIVED

• El Mahdiui M, Smit JM, van Rosendael AR, Neglia D, Knuuti J, Saraste A, Buechel RR, Teresinska A, Pizzi MN, Roque A, Magnacca M, Mertens BJ, Caselli C, Rocchiccioli S, Parodi O, Pelosi G, Scholte AJ. Sex differences in coronary plaque changes assessed by serial computed tomography angiography. Int J Cardiovasc Imaging. 2021 Jul;37(7):2311-2321. doi: 10.1007/s10554-021-02204-4. Epub 2021 Mar 10.

  PMID: 33694122 DERIVED

• Sbrana S, Campolo J, Clemente A, Bastiani L, Cecchettini A, Ceccherini E, Caselli C, Neglia D, Parodi O, Chiappino D, Smit JM, Scholte AJ, Pelosi G, Rocchiccioli S. Blood Monocyte Phenotype Fingerprint of Stable Coronary Artery Disease: A Cross-Sectional Substudy of SMARTool Clinical Trial. Biomed Res Int. 2020 Jul 27;2020:8748934. doi: 10.1155/2020/8748934. eCollection 2020.

  PMID: 32802883 DERIVED

Related Links

• H2020 project website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Coordinator

Model Details: prospective study with serial CCTA

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: April 14, 2016
• Primary Completion: October 30, 2017
• Study Completion: December 30, 2017
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share