High Performance Computing of Personalized Cardio Component Models (HEART)

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

Detailed Description

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:

  • 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).
• Non-invasive pressure measurements: cuff-based measurements at the left and right arm, before echocardiography and angiography
• Invasive pressure measurements: rest - aortic pressure (Pa), distal pressure (Pd), Pd/Pa ratio; hyperemia - aortic pressure (Pa), distal pressure (Pd), FFR (Pd/Pa)

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania
    • Spitalul Clinic de Urgenta Bucuresti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled to undergo clinically-indicated non-emergent invasive coronary angiography, with suspected coronary artery disease

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net reclassification index when using echocardiography data as input parameters for the computational model (in addition to the angiographic data)	Coronary hemodynamic indices (FFR, basal Pd/Pa) are determined from the computational model in two configurations: with and without echocardiography based input data. We evaluate the net reclassification index of the computed coronary hemodynamic indices when echocardiography based input data is used (as compared to the gold standard represented by the measured coronary hemodynamic indices).	up to 18 months
Numerical correlation between computed and measured distal coronary pressure at rest and hyperemia	Distal coronary pressure at rest and hyperemia are measured invasively and are extracted from the computational model. The correlation between measured and computed quantities is evaluated.	up to 18 months

Collaborators and Investigators

• Sponsor: Transilvania University of Brasov
• Collaborators: Spitalul Clinic de Urgenţǎ Bucureşti; Siemens Corporate Technology Romania; Universitatea Politehnica Bucureşti
• Investigators: Principal Investigator: Constantin Suciu, Conf. dr. ing., Siemens Corporate Technology Romania

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: September 6, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Coronary artery disease; non-invasive; diagnosis; FFR; computational model
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 130_2012