Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT03404258
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT03404258
Study Brief:
Protocol Section:
NCT03404258