High Performance Computing of Personalized Cardio Component Models

NCT02235883 | Completed

• 1 other identifier: 130_2012
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; FFR; diagnosis; computational model; non-invasive

Outcome Measures

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.

  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)

  up to 18 months

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

  up to 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Transilvania University of Brasov: lead
• Spitalul Clinic de Urgenţǎ Bucureşti: collaborator
• Siemens Corporate Technology Romania: collaborator
• Universitatea Politehnica Bucureşti: collaborator

Study Sites (1)

Spitalul Clinic de Urgenţǎ Bucureşti

Bucharest, Romania

Location

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease; Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Constantin Suciu, Conf. dr. ing.

  Siemens Corporate Technology Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Conf. dr. ing. Constantin Suciu

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: September 10, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

RO (1)