"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT" (SMARTool)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04448691|
Recruitment Status : Completed
First Posted : June 26, 2020
Last Update Posted : June 26, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Management/Treatment of Coronary Artery Disease||Diagnostic Test: CCTA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||275 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective study with serial CCTA|
|Masking:||None (Open Label)|
|Official Title:||"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT"|
|Actual Study Start Date :||April 14, 2016|
|Actual Primary Completion Date :||October 30, 2017|
|Actual Study Completion Date :||December 30, 2017|
Suspected coronary disease patients enrolled in EVINCI trial with CCTA where recalled for follow up CCTA and blood sampling
Diagnostic Test: CCTA
requested follow up CCTA
- coronary artery disease progression assessed by CCTA [ Time Frame: 6 years CCTA follow up ]