Pulmonary Hypertension Clinical Trial
Official title:
Integrated Computational modelIing of Right Heart Mechanics and Blood Flow Dynamics in Congenital Heart Disease ("INITIATE")
Advances in paediatric cardiology and cardiac surgery have enabled the survival of most
patients born with congenital heart disease (CHD) into adulthood. Many CHD patients have
undergone palliative or reparative surgery earlier in life. As patients survive into
adulthood, they may need intervention or surgery for residual haemodynamic lesions. This is
because they are at risk of arrhythmias secondary to structure heart disease and are
susceptible to acquired heart disease. In these patients, pre-operative and post-operative
evaluation of right ventricular (RV) structure (shape and volume) and function is an
essential component of clinical management.
Advances have been made in cardiac imaging so that accurate assessment of the right heart
chamber in terms of its structure, function and physiology is possible. However, this
technology has as yet never been applied in an effort to comprehensively assess RV structure,
function and physiology. Cardiac Magnetic Resonance (CMR) will be used in this comprehensive
assessment of structure and function. Thus, this research will allow development of a
comprehensive integrated biomedical engineering (BME) R&D platform for in-depth study and
clinical diagnosis of the RV structure-function relationship and physiology and its
association with biomarker, and exercise capacity in CHD.
The incidence of Congenital Heart Disease (CHD) in live new-borns is estimated to vary from
4.1/1000 to 12.3/1000. The improvement in survival of CHD patients has led to burgeoning
numbers of grown-up CHD.The majority of these CHD patients face a lifetime of problems
including RV dilation, ventricular arrhythmias, and sudden cardiac death.Considering
inflation to visit costs and added image technology for diagnosis, the cost of each patient
is expected to increase .In contrast to adult patients with acquired heart disease,
abnormalities of the RV are ubiquitous in children and adults with CHD.
Currently, clinical evaluation includes ECG and pulse oximetry alongside clinical
examination. Investigation of RV anatomy and physiology is evolving from a reliance on
invasive studies (right heart catheterization or RHC) to non-invasive imaging techniques such
as echocardiography, nuclear scintigraphy, computed tomography, and CMR .2D echocardiography
is largely operator dependent and suffers from poor inter-study reproducibility.The complex
geometry of the RV makes it difficult to accurately quantify remodelling before and after
intervention. Nuclear scintigraphy and computed tomography (CT) are constrained by the need
for ionizing radiation as well as the poor temporal resolution of the technique.Importantly,
existing CMR analytics fail to exploit the full potential of the rich CMR image dataset, and
do not yield information on regional RV remodelling, muscle stiffness and blood flow
characterization.
Due to the challenges mentioned above, other than RV volumes and ejection fraction, other
changes in RV shape and haemodynamics have yet to be considered in the official guidelines
used to define eligibility for surgery and to quantify risk of operation. It is plausible
that incorporation of additional variables that more comprehensively characterizes fine
alterations in RV structure, function and haemodynamics in large risk-stratification models,
such as the EuroSCORE and the Society of Thoracic Surgeons' Risk Calculator, may enhance risk
stratification and prognostication.
Incorporating novel exploratory RV functional indices (e.g. curvedness, area strain) and
computational methods (e.g. CFD, FSI simulations), and then correlating these with clinical
and cardiopulmonary exercise test outcomes will allow investigators to have established an
unprecedentedly sizeable and rich clinical imaging database that serves both as a touchstone
for clinical reference, as well as a repository for future exploratory research.
Investigators tend to develop a comprehensive (BME) Research and Development platform for
in-depth study of RV mechanics, blood flow and function in Congenital Heart Disease.
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