Back to resultsRepeatability of OCT and IV-US in Pulmonary Arterial Hypertension
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Patients with Pulmonary Arterial Hypertension
Sponsored by
About this trial
This is an interventional health services research trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines
- With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines
Exclusion Criteria:
- That according to investigator criteria cannot participate in the trial
Sites / Locations
- Hospital Vall d'Hebron
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary Arterial Hypertension
Arm Description
Patients with Pulmonary Arterial Hypertension
Outcomes
Primary Outcome Measures
Image measurements
Repeat acquisitions to be made in the same regions and in locations
Secondary Outcome Measures
Full Information
NCT ID
NCT03105934
First Posted
April 4, 2017
Last Updated
February 9, 2018
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03105934
Brief Title
Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension
Official Title
Repeatability of Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IV-US) in Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
January 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Arterial Hypertension
Arm Type
Experimental
Arm Description
Patients with Pulmonary Arterial Hypertension
Intervention Type
Procedure
Intervention Name(s)
Patients with Pulmonary Arterial Hypertension
Intervention Description
2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.
Primary Outcome Measure Information:
Title
Image measurements
Description
Repeat acquisitions to be made in the same regions and in locations
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines
With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines
Exclusion Criteria:
That according to investigator criteria cannot participate in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enric Domingo, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension
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