Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01508780
Status:
WITHDRAWN
Last Update Posted:
2014-02-13
First Post:
2012-01-03
Brief Title:
Combined Use of Angiography Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Combined Use of Angiography Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan
Status:
WITHDRAWN
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to complex study protocol no patients have been enrolled in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular remodeling The investigators believe that this study will help document the nature of beneficial changes that occur in patients with Pulmonary Arterial Hypertension PAH in response to bosentan therapy In turn demonstrating that changes in pulmonary vascular structure and function accompany clinical improvement
Detailed Description:
Subjects will have Optical coherence tomography OCT and Intravascular Ultrasound IVUS imaging during the right heart catheterization that diagnoses them as having PAH Subjects will start their bosentan and will be followed by monthly clinic visits for 4 months At 4 months they will have repeat OCT and IVUS imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None