"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"
Condition: Management/Treatment of Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

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.
    


Intervention name(s): CCTA
Intervention type(s): Diagnostic Test
Intervention description(s): requested follow up CCTA
Intervention model: Single Group Assignment
Intervention model description: prospective study with serial CCTA
Masking: None (Open Label)
Primary purpose: Diagnostic