Study on the Predicting Model for Spontaneous Closure of Perimembranous Ventricular Septal Defects in Children- An Observational Research Based on the Real World
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Proportion of participants with spontaneous closure of perimembranous ventricular septal defect confirmed by echocardiography
Study Overview
Brief Summary
The objective of this study is to establish a more comprehensive model for evaluating the condition of children with ventricular septal defect and predicting the probability and time of their spontaneous Closure.
Detailed Description
This is an observational study with sufficient and complete preliminary research and pre-experimental foundations. This study used the "National Congenital Heart Disease Collaboration Network" platform to retrospectively collect electronic medical record of children with Perimembranous Ventricular Septal Defect（PMVSD）that met the criteria of this study. The minimum sample size is estimated to be 4,500. According to the observation of the natural course of PMVSD in children, they were divided into PMVSD spontaneously closed group and unclosed group. The objective of this study is to establish a data model, which can predict the spontaneous closure probability of congenital perimembranous ventricular septal defect and provide reliable basis for clinical diagnosis and therapy. Through the experience screening of clinical experts and big clinical data mining of large samples, PMVSD spontaneous closure related variables were extracted and were used to establish a more accurate and objective prediction for the natural course of PMVSD.This could provide reliable information for the clinical surgery timing and indications urgery thus is of important social significance and economic value.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The initial diagnosis age is from birth to 14 years old
- •Ultrasonography confirmed the presence of simple PMVSD or other simple congenital heart diseases without other complicated heart malformations (such as pulmonary venous drainage, conus trunk malformation, interruption of aortic arch, primary pulmonary hypertension, etc.)
- •No major disease at first diagnosis (life-threatening organic disease not caused by congenital heart disease)
- •The patient or guardian voluntarily signs the informed consent form
Exclusion Criteria
- •The initial diagnosis age>14 years old.
- •With complicated congenital heart disease (such as pulmonary venous ectopic drainage, conus trunk malformation, interruption of aortic arch, primary pulmonary hypertension, etc.)
- •Serious diseases of other organs
- •Unable to cooperate with the doctor to complete regular outpatient follow-up or give up treatment
Outcomes
Primary Outcomes
Proportion of participants with spontaneous closure of perimembranous ventricular septal defect confirmed by echocardiography
Time Frame: From baseline to December 2022
Spontaneous closure is defined as the absence of a ventricular septal defect shunt on color Doppler echocardiography, without prior surgical or transcatheter closure intervention.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jing Sun
Doctor of Department of Pediatric Cardiology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine