ClinicalTrials.gg
CompletedNCT02235883HEARTUpdated Apr 25, 2018

High Performance Computing of Personalized Cardio Component Models

An observational study in Coronary Artery Disease, sponsored by Transilvania University of Brasov. Completed at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-25.

Sponsored by Transilvania University of Brasov · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
94
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 28 studies in Coronary Artery Disease with a site in Romania — 3 open to participants now, 6 under way, 3 of them phase 3. Coronary Artery Disease · Romania.

Enrollment
9th of 10
94 · median 655
Started
2014
with 2 others
Observational
10 of 28
1 open now
Registered
15th of 28
by date

Among the 28 studies in Coronary Artery Disease with a site in Romania, this one is the 9th largest by enrollment of the 10 observational ones, is one of 3 that started in 2014, is one of 10 observational ones, and was the 15th registered.

By phase

28 studies; the count open now beside each. This study's row is marked.

Observationalthis study10 · 1 open
Phase 39 · 0 open
No phase5 · 1 open
Phase 42 · 0 open
Phase 1/21 · 0 open
Phase 2/31 · 1 open

By the year they started

First in 2002; this study’s year is marked. 3 started in 2014.

Size and results

Median enrollment 5,130 across the 18 interventional studies, 655 across the 10 observational. Of the 19 that completed or were terminated, 8 (42%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 28 studies in Coronary Artery Disease with a site in Romania, or all of them as a file.
02

Study 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

Read the 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)
03

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary artery disease
  • FFR
  • diagnosis
  • computational model
  • non-invasive
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects scheduled to undergo clinically-indicated non-emergent invasive coronary angiography, with suspected coronary artery disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age >18 years
  • providing written
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
94 participants (actual)
Patient registry
No
06

What researchers measure

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)

    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.

    Time frame: up to 18 months

Secondary outcomes

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

    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).

    Time frame: up to 18 months

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

    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.

    Time frame: up to 18 months

07

Study locations

1 site
  • Spitalul Clinic de Urgenţǎ Bucureşti
    Bucharest, Romania
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2014, a primary completion of Dec 2016 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2014
First posted
Sep 10, 2014
Start
Aug 2014
Primary completionActual
Dec 2016
CompletionActual
Jan 2017
Last update
Apr 25, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02235883
Lead sponsor
Transilvania University of Brasov
Collaborators
Spitalul Clinic de Urgenţǎ Bucureşti, Siemens Corporate Technology Romania, Universitatea Politehnica Bucureşti
Responsible party
Lucian Itu (Conf. dr. ing. Constantin Suciu, Siemens Corporate Technology Romania) — Principal investigator
First posted
Sep 10, 2014
Start date
Aug 2014
Primary completion
Dec 2016
Completion
Jan 2017
Last update
Apr 25, 2018

Study contacts

Constantin Suciu, Conf. dr. ing.
principal investigator · Siemens Corporate Technology Romania
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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