High Performance Computing of Personalized Cardio Component Models

NCT ID: NCT02235883

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-01-31

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)

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spitalul Clinic de Urgenţǎ Bucureşti

UNKNOWN

Sponsor Role: collaborator

Siemens Corporate Technology Romania

INDUSTRY

Sponsor Role: collaborator

Universitatea Politehnica Bucureşti

UNKNOWN

Sponsor Role: collaborator

Transilvania University of Brasov

OTHER

Sponsor Role: lead

Responsible Party

Lucian Itu

Conf. dr. ing. Constantin Suciu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Constantin Suciu, Conf. dr. ing.

Role: PRINCIPAL_INVESTIGATOR

Siemens Corporate Technology Romania

Locations

Spitalul Clinic de Urgenţǎ Bucureşti

Bucharest, , Romania

Countries

Romania

Related Links

http://heart.unitbv.ro/

Related Info

Other Identifiers

130_2012

Identifier Type: -

Identifier Source: org_study_id