Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension
February 9, 2018 updated by: Hospital Universitari Vall d'Hebron Research Institute
Repeatability of Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IV-US) in Pulmonary Arterial Hypertension
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Barcelona, Spain, 08035
- Hospital Vall d'hebrón
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pulmonary Arterial Hypertension
Patients with Pulmonary Arterial Hypertension
|
2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Image measurements
Time Frame: 12 months
|
Repeat acquisitions to be made in the same regions and in locations
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Enric Domingo, MD, Hospital Vall d'hebrón
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
October 18, 2017
Study Completion (Actual)
January 25, 2018
Study Registration Dates
First Submitted
April 4, 2017
First Submitted That Met QC Criteria
April 4, 2017
First Posted (Actual)
April 10, 2017
Study Record Updates
Last Update Posted (Actual)
February 12, 2018
Last Update Submitted That Met QC Criteria
February 9, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IVUS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.