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Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

NCT ID: NCT02026531

Last Updated: 2015-09-30

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

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-09-30

Brief Summary

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The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3-Helium inhalation gas

This is a pilot study. The aim is to recruit 20 patients who will all receive the product under investigation.

Group Type EXPERIMENTAL

3-Helium gas

Intervention Type OTHER

3-Helium gas for MRI contrast

Interventions

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3-Helium gas

3-Helium gas for MRI contrast

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All cases referred to the clinic for assessment for possible pulmonary hypertension.

Exclusion Criteria

* patients with a cardiac pacemaker or retained temporary pacing wire
* patients with aneurysm clip
* non MRI compatible heart valve prosthesis
* intra orbital metalic foreign body
* pregnancy
* metal prosthesis/spinal rods
* retained shrapnel
* cochlear implants/bladder stimulator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sheffield

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlie Elliot, MBChB MRCP

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Sheffield Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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STH14070

Identifier Type: -

Identifier Source: org_study_id