Clinical trial NCT02235883: High Performance Computing of Personalized Cardio Component Models
Official title: High Performance Computing of Personalized Cardio Component Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
FFR
diagnosis
computational model
non-invasive
Lead sponsor: Transilvania University of Brasov
Sponsor class: OTHER
Collaborators: name: Spitalul Clinic de Urgenţǎ Bucureşti
name: Siemens Corporate Technology Romania
name: Universitatea Politehnica Bucureşti
First posted: 2014-09-10
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects scheduled to undergo clinically-indicated non-emergent invasive coronary angiography, with suspected coronary artery disease

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)

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

Primary outcomes:
measure: 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)
timeFrame: up to 18 months
Secondary outcomes:
measure: Net reclassification index when using echocardiography data as input parameters for the computational model (in addition to the angiographic data)
timeFrame: up to 18 months
measure: Numerical correlation between computed and measured distal coronary pressure at rest and hyperemia
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenţǎ Bucureşti
Study officials:
affiliation: Siemens Corporate Technology Romania
name: Constantin Suciu, Conf. dr. ing.
role: PRINCIPAL_INVESTIGATOR
References: