Management/Treatment of Coronary Artery Disease Clinical Trial
— SMARToolOfficial title:
"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"
| NCT number | NCT04448691 |
| Other study ID # | 23534 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 14, 2016 |
| Est. completion date | December 30, 2017 |
| Verified date | June 2020 |
| Source | Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 275 |
| Est. completion date | December 30, 2017 |
| Est. primary completion date | October 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. male and female subjects 2. aged 45-75 years 3. caucasian population 4. 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 5. submitted to clinical Follow-up in the last 6 months with stable clinical conditions and documented CHD or persistent intermediate/high probability of CHD 6. Signed informed consents (clinical and genetic) Exclusion Criteria: 1. Multi-vessel severe disease (3 vessels and/or LM disease with >90% stenosis). 2. Severe coronary calcification (CAC score > 600). 3. Having undergone surgical procedures related to heart diseases (CABG, valve replacement, CRT or CRTD treatment, any surgery of the heart or arteries). 4. Documented MACE at history (myocardial infarction, severe heart failure, recurrent angina) in the last 6 months with/without revascularization 5. Documented severe peripheral vascular disease (carotid, femoral) 6. Surgery of carotid and/or peripheral arteries or cerebral ischemic attack 7. History/surgery of Abdominal Aortic Aneurysm(AAA). 8. Severe Heart failure (NYHA Class III-IV) 9. LV dysfunction (left ventricle EF <40%). 10. Atrial fibrillation. 11. Lack of written informed consent (clinical consent and/or genetic consent) 12. Pregnancy (evaluated by urine test) and breastfeeding 13. Active Cancer 14. Asthma 15. Severe untreated Hypertension (arterial blood pressure = 170/110 mmHg) 16. Cardiomyopathy or congenital heart disease 17. Significant valvular disease (hemodynamically significant valvular stenosis or insufficiency by echoDoppler) 18. Renal dysfunction (creatinine > 1.3 mg/dL) 19. Chronic Kidney Disease (eGFR < 30 ml/min/1.73 m2) 20. Hepatic failure (at least 3 of the following: albumin < 3.5 g/dL; prolonged prothrombin time-PT; jaundice; ascites) 21. Waldenstrom disease 22. Multiple myeloma 23. Autoimmune/Acute inflammatory disease 24. Previous severe adverse reaction to iodine contrast agent 25. Positivity at blood tests for HIV, Hepatitis B and C (CRF number 1-clinical evaluation) - |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy | Azienda USL 12 Versilia, Federico II University, Institut Catala de Salut, Institute of Cardiology, Warsaw, Poland, Turku University Hospital, University of Zurich |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | coronary artery disease progression assessed by CCTA | 6 years CCTA follow up |