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临床试验/NCT02791061
NCT02791061Unknown不适用

Segmentation, Structural Reconstruction and Quantification of Right Ventricular Remodeling in Congenital Heart Disease for Clinical Decision-making and Treatment Planning.

National Heart Centre Singapore1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
54
试验地点
1
主要终点
First occurrence of cardiovascular event

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
13 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Survivors of TOF repair more than one year after repair without pulmonary stenosis (Doppler gradient more than 30mmHg) OR
  • Patients with moderate or severe pulmonary stenosis (Echo Doppler gradient more than 30mmHg)
  • Patients without prior Pulmonary Valve Replacement (PVR)
  • Written informed Consent obtained
  • Aged 13 to 80 years old

排除标准

  • Age less than 13
  • Contraindication to MRI Examination
  • Cardiac Pacemaker
  • Brain Aneurysm OR clips
  • Electronic implants OR prosthesis
  • Eye metal foreign body injury
  • Severe claustrophobia
  • Known severe impairment, glomerular filtration rate GFR less than 30 ml/min/BSA
  • Non Cardiac illness with life expectancy of less than 2 years
  • Previous heart kidney liver or lung transplantation Pregnancy

结局指标

主要结局

First occurrence of cardiovascular event

时间窗: 1 Year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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