ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.
研究概览
简要总结
This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and complications associated with decreased post-operative pulmonary blood flow in single ventricle patients undergoing superior cavo-pulmonary anastomosis (SCPA). The study will utilize a combined targeted and untargeted approach to both optimize translation of a promising existing biomarker and efficiently identify novel biomarkers and potential therapeutic targets in this population.
详细描述
Overall Hypothesis: Endothelin-1 (ET1) and associated dysregulation of key metabolic pathways decrease pre-operative pulmonary blood vessel development and increase post-operative pulmonary blood vessel resistance leading to decreased pulmonary blood flow in patients undergoing SCPA.
For enrolled patients, collected data will include:
- 3 mL blood sample (x2) at pre-SCPA catheterization.
- 3 mL blood samples at 2, 24, and 48 hours post-operative.
- Urine sample pre-operatively and post-operatively
- Collection of otherwise-discarded operative tissue sample from the pulmonary artery.
- Collection of clinical data, demographic data, and results of routine, post-operative hemodynamic monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital heart disease patients undergoing catheterization for pre-SPCA evaluation or undergoing SCPA without plans for cardiac catheterization (utilizing data from a previously performed clinical catheterization).
- •All patients will have age from 31 days to 2 years.
排除标准
- •Patients who will remain post-op with a pulsatile source of pulmonary blood flow in addition to the cavo-pulmonary anastomosis (so called "1.5 ventricle" repair) will be excluded.
- •Due to limitations in acceptable sample blood volumes for research, patients with weight <4kg will be excluded.
- •Patients will not be excluded on the basis of gender, ethnicity, genetic diagnosis, gestational age at birth, non-cardiac comorbidity, or pre-operative medication regimen.
研究组 & 干预措施
Study Patients
Infants between 1 month and 2 years of age undergoing evaluation for SCPA candidacy.
干预措施: Research Blood Sampling (Other)
Control Patients
Infants between 3 months and 12 months of age with no known cardio-pulmonary disease, no active infection, and no known genetic abnormality undergoing elective surgery for a non-cardiac indication.
干预措施: Research Blood Sampling (Other)
结局指标
主要结局
Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.
时间窗: 48 hours post-operatively
Difference in ET1 concentration between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.
时间窗: 48 hours post-operatively
次要结局
- Association between ET1 concentration at pre-SCPA catheterization in study patients and clinical metrics of pre-operative pulmonary adequacy.(48 hours post-operatively)
- Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy.(48 hours post-operatively)