Coronary Artery DiseaseHEARTNCT02235883
High Performance Computing of Personalized Cardio Component Models
An observational study of Coronary Artery Disease, run by Transilvania University of Brasov at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 94 participants
- Where
- 1 siteRomania
- Study dates
- Aug 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects scheduled to undergo clinically-indicated non-emergent invasive coronary angiography, with suspected coronary artery disease
Who may be able to join
- 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)
Who cannot join
- prior PCI
- prior bypass surgery
- prior valve surgery or replacement
- significant arrhythmia
- very low systolic BP (<90 mmHg)
- abnormally high HR (>120 bpm)
Show all 9Show fewer
- significant Left Main disease
- STEMI or NSTEMI
- suspected microvascular disease
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, FFR, diagnosis, computational model, non-invasive
- Medical subject headings
- Coronary Artery Disease, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 18 months
Secondary outcomes (2)
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).
Measured: up to 18 months
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.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transilvania University of Brasov
- Sponsor type
- University, hospital or other
- Collaborators
- Spitalul Clinic de Urgenţǎ Bucureşti, Siemens Corporate Technology Romania, Universitatea Politehnica Bucureşti
- Responsible party
- Principal investigator, Lucian Itu, Siemens Corporate Technology Romania
- Investigators
- Constantin Suciu, Conf. dr. ing., Principal investigator, Siemens Corporate Technology Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235883
- Sponsor's protocol ID
- 130_2012
- Acronym
- HEART
- Status last verified
- Apr 2018
- First submitted
- 26 Aug 2014
- Last updated
- 25 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Performance Computing of Personalized Cardio Component Models
- ClinicalTrials.gov ID
- NCT02235883
- Acronym / sponsor ID
- HEART / 130_2012
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, FFR, diagnosis, computational model, non-invasive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Transilvania University of BrasovUniversity, hospital or other
- Collaborators
- Spitalul Clinic de Urgenţǎ Bucureşti, Siemens Corporate Technology Romania, Universitatea Politehnica Bucureşti
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled to undergo clinically-indicated non-emergent invasive coronary angiography, with suspected coronary artery disease
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- prior PCI
- prior bypass surgery
- prior valve surgery or replacement
- significant arrhythmia
- very low systolic BP (<90 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Numerical correlation between computed and measured distal coronary pressure at rest and hyperemia
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantin Suciu, Conf. dr. ing. principal investigator
Siemens Corporate Technology Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Transilvania University of Brasov at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.