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High Performance Computing of Personalized Cardio Component Models (HEART)

T

Transilvania University of Brasov

Status

Completed

Conditions

Coronary Artery Disease

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02235883
130_2012

Details and patient eligibility

About

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

Full 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)

Enrollment

94 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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