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NCT03105934 Clinical Trial

Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:
Repeatability of Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IV-US) in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03105934
Other study ID # IVUS
Secondary ID
Status Completed
Phase N/A
First received April 4, 2017
Last updated February 9, 2018
Start date April 2016
Est. completion date January 25, 2018

Study information
Verified date February 2018
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 25, 2018
Est. primary completion date October 18, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Patients with Pulmonary Arterial Hypertension
2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.

Locations
Country Name City State
Spain Hospital Vall d'Hebron Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Image measurements Repeat acquisitions to be made in the same regions and in locations 12 months
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