Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06122922
Status:
WITHDRAWN
Last Update Posted:
2024-01-23
First Post:
2023-11-03
Brief Title:
Xenon MRI in Stable Pulmonary Hypertension Jupiter AUGEAN
Sponsor:
Bastiaan Driehuys
Organization:
Duke University
Study Overview
Official Title:
Xenon MRI in Stable Patients With Pulmonary Hypertension
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this project is to determine how pulmonary vascular remodeling in Pulmonary Arterial Hypertension PAH at cellular and pathological level is associated with gas exchange physiology changes and hemodynamics monitored with 129Xe MRIMRS and how these signals change with disease progression or treatment
Detailed Description:
The clinical and research need for noninvasive biomarkers in pulmonary arterial hypertension PAH has led the study team to develop 129Xe magnetic resonance imaging 129Xe MRI to image pulmonary vascular pathology through quantitative 3D maps of gas transfer across the pulmonary blood-gas barrier 129Xe MRI in combination with 129Xe spectroscopy MRS has a unique signature in PAH and can simultaneously measure capillary blood volume and hemodynamic changes associated with pulmonary vascular remodeling Wang 19a This project aims to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is related to gas exchange physiology changes and hemodynamics monitored with 129Xe MRIMRS and the change in these signals over one year in patients with stable PAH Our central hypothesis is that patients with stable PAH will display persistent abnormalities on 129Xe MRIMRS consistent with pulmonary vascular remodeling and that some patients may have worsening of their disease while appearing to be stable disease
The study team will assess the ability of 129Xe MRI to longitudinally monitor disease progression in patients with stable PAH First the team will enroll stable PAH patients and obtain detailed clinical information to be stored in the REDCAP database The study team will then follow this cohort of PAH subjects for one year performing 129Xe MRI scans at baseline 3 months 6 months and one year in addition to their standard-of-care assessments including appointments labs echo and 6MWTs
The study team will assess the ability of 129Xe MRI to longitudinally monitor disease progression in patients with stable PAH First the team will enroll stable PAH patients and obtain detailed clinical information to be stored in the REDCAP database The study team will then follow this cohort of PAH subjects for one year performing 129Xe MRI scans at baseline 3 months 6 months and one year in addition to their standard-of-care assessments including appointments labs echo and 6MWTs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None