Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT02791061
Status:
UNKNOWN
Last Update Posted:
2017-03-31
First Post:
2016-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of RV Remodeling in Congenital Heart Disease
Sponsor:
National Heart Centre Singapore
Organization:
Study Overview
Official Title:
Segmentation, Structural Reconstruction and Quantification of Right Ventricular Remodeling in Congenital Heart Disease for Clinical Decision-making and Treatment Planning.
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RVShape
Brief Summary:
The primary aims of this study are to 1. Develop an automated method of quantitation of RV remodeling in terms of regional RV surface curvature and area strain and assess the feasibility, repeatability and accuracy in normal subjects and patients with repaired TOF, patients with PS
The secondary study aims of this study are to
1\. Compare the differences of RV remodeling in repaired TOF patients, PS patients with sex and age-matched controls 2, Assess the relationship of our proposed parameters to global RV function and exercise capacity in repaired TOF patients and PS patient
The secondary study aims of this study are to
1\. Compare the differences of RV remodeling in repaired TOF patients, PS patients with sex and age-matched controls 2, Assess the relationship of our proposed parameters to global RV function and exercise capacity in repaired TOF patients and PS patient
Detailed Description:
Right ventricular (RV) function is increasingly recognized to play an important role in the clinical status and long-term outcome in patients with congenital heart disease (CHD) as well as ischemic cardiomyopathy with left ventricular (LV) dysfunction. However, quantitation of RV characteristics and function, in particular for regional RV characteristics and function, are still challenging due to its complex morphology and its thin wall with coarse trabeculations. The remarkable improvement in survival of CHD patients has led to a continuously growing number of grown-up CHD. In addition, some defects (e.g., Ebstein's anomaly) may be diagnosed for the first time in adult. Majority of these CHD patients face a lifetime of problems including RV dilation, ventricular arrhythmias, and sudden cardiac death. Therefore, accurate depictions of the RV remodeling process facilitate disease would aid in surveillance and monitoring of therapeutic efficacy.
CHD patients, even after corrective surgery, need lifetime surveillance and yearly clinical evaluation. Currently, clinical evaluation includes ECG and pulse oximetries alongside clinical examination. Investigation of anatomy and physiology of RV are changing from invasive studies (right heart catheterization) to noninvasive imaging techniques including: echocardiography, nuclear scintigraphy, computed tomography, and cardiac magnetic resonance (CMR) imaging. In short, echocardiography is largely operator dependent and suffers from poor inter-study reproducibility. The complex geometry of the RV makes it difficult to accurately quantify its remodeling before and after intervention. Nuclear scintigraphy and computed tomography are constrained by the need for ionizing radiation as well as the poor temporal resolution of the technique. CMR has been considered the golden reference technique for RV volume and ejection fraction.
From current state-of-the-art in CMR, generation of RV volume and ejection fraction, global measures of RV remodeling, requires extensive manual contouring. Most important, there is lacking of regional RV remodeling measures.
CHD patients, even after corrective surgery, need lifetime surveillance and yearly clinical evaluation. Currently, clinical evaluation includes ECG and pulse oximetries alongside clinical examination. Investigation of anatomy and physiology of RV are changing from invasive studies (right heart catheterization) to noninvasive imaging techniques including: echocardiography, nuclear scintigraphy, computed tomography, and cardiac magnetic resonance (CMR) imaging. In short, echocardiography is largely operator dependent and suffers from poor inter-study reproducibility. The complex geometry of the RV makes it difficult to accurately quantify its remodeling before and after intervention. Nuclear scintigraphy and computed tomography are constrained by the need for ionizing radiation as well as the poor temporal resolution of the technique. CMR has been considered the golden reference technique for RV volume and ejection fraction.
From current state-of-the-art in CMR, generation of RV volume and ejection fraction, global measures of RV remodeling, requires extensive manual contouring. Most important, there is lacking of regional RV remodeling measures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: