Skip to main content
Clinical Trials/NCT02235883
NCT02235883CompletedNot Applicable

High Performance Computing of Personalized Cardio Component Models

Transilvania University of Brasov1 site in 1 country94 target enrollmentStarted: August 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
94
Locations
1
Primary Endpoint
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)

Study Overview

Brief Summary

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

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Transilvania University of Brasov
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lucian Itu

Conf. dr. ing. Constantin Suciu

Siemens Corporate Technology Romania

Study Sites (1)

Loading locations...

Similar Trials

High Performance Computing of Personalized... | Clinical Trial