Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT03404258
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
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:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: