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Completed

NCT Number: NCT02235883

High Performance Computing of Personalized Cardio Component Models

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spitalul Clinic de Urgenţǎ Bucureşti

Bucharest, Romania

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

    Time frame: 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.

Secondary outcomes

  1. Net reclassification index when using echocardiography data as input parameters for the computational model (in addition to the angiographic data)

    Time frame: up to 18 months

    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).

  2. Numerical correlation between computed and measured distal coronary pressure at rest and hyperemia

    Time frame: up to 18 months

    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.

Sponsors and collaborators

Lead sponsor

Transilvania University of Brasov

Other

Collaborators

  • Siemens Corporate Technology Romania
  • Spitalul Clinic de Urgenţǎ Bucureşti
  • Universitatea Politehnica Bucureşti

Registry information

Acronym: HEART

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 10, 2014
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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