Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension

NCT ID: NCT03105934

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-01-25

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pulmonary Arterial Hypertension

Patients with Pulmonary Arterial Hypertension

Group Type EXPERIMENTAL

Patients with Pulmonary Arterial Hypertension

Intervention Type PROCEDURE

2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.

Interventions

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Patients with Pulmonary Arterial Hypertension

2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enric Domingo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Locations

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Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IVUS

Identifier Type: -

Identifier Source: org_study_id

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