High Performance Computing of Personalized Cardio Component Models
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Accuracy of coronary hemodynamic indices extracted from the computational model of the coronary circulation as compared to the invasively measured indices (FFR, basal Pd/Pa)
研究概览
简要总结
The objective of the HEART Study is to develop a multiscale model of the coronary circulation based on multimodal imaging data (angiography, echocardiography). The predictive comprehensive multi-scale model, developed during this proof-of-concept study, will be used for analyzing functional aspects of coronary artery disease. Model validation is performed against invasive measurements
详细描述
The main objective of HEART is the development and validation of a patient-specific multiscale computational model of the coronary circulation with high predictive power in healthy and diseased vessels:
- Comprehensive modeling of the anatomical and hemodynamic phenomena in the coronary circulation based on input data acquired from both angiography and echocardiography;
- Assessment of functional parameters and subsequent validation of the models;
- High performance computing architecture for efficiently addressing the multi-scale complexity, which is a critical requirement for translation into clinical decision making.
Patient measurements used as input data for the multiscale models, or for validating the computational results include:
-
Angiography: targeted angiographic views include LAO 30, LAO 30/20 cranial, LAO 30/20 caudal, RAO 30 (RCA views) and RAO 25/25 caudal, RAO 0/40 caudal, RAO 10/40 cranial, LAO 50/20 cranial, LAO 50/20 caudal (LCA views)
-
Echocardiography:
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Standard apical acquisitions (2D harmonic 4-chamber, 2-chamber, 3-chamber)
-
Color flow Doppler/spectral Doppler (MR, AI, TR evaluation; CW and PW spectral Doppler)
-
Three-dimensional imaging (From apical 4-chamber view one ECG-triggered real time complete full volume acquisition including LV and LA - 1 acquisition at low volume per second (VPS) rate and one at high VPS, real time volumetric color flow Doppler, cover MV and AV).
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Non-invasive pressure measurements: cuff-based measurements at the left and right arm, before echocardiography and angiography
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Invasive pressure measurements: rest - aortic pressure (Pa), distal pressure (Pd), Pd/Pa ratio; hyperemia - aortic pressure (Pa), distal pressure (Pd), FFR (Pd/Pa)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years
- •providing written informed consent
- •scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)
- •likelihood of stenosis in one of the main coronary epicardial vessels (LAD, LCx, RCA)
排除标准
- •prior PCI
- •prior bypass surgery
- •prior valve surgery or replacement
- •significant arrhythmia
- •very low systolic BP (<90 mmHg)
- •abnormally high HR (>120 bpm)
- •significant Left Main disease
- •STEMI or NSTEMI
- •suspected microvascular disease
结局指标
主要结局
Accuracy of coronary hemodynamic indices extracted from the computational model of the coronary circulation as compared to the invasively measured indices (FFR, basal Pd/Pa)
时间窗: up to 18 months
Coronary hemodynamic indices (FFR, basal Pd/Pa) are measured invasively and are computed from the computational model of coronary hemodynamics. The diagnostic accuracy of the computed hemodynamic indices is evaluated against the measured hemodynamic indices.
次要结局
- Net reclassification index when using echocardiography data as input parameters for the computational model (in addition to the angiographic data)(up to 18 months)
- Numerical correlation between computed and measured distal coronary pressure at rest and hyperemia(up to 18 months)
研究者
Lucian Itu
Conf. dr. ing. Constantin Suciu
Siemens Corporate Technology Romania