Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

NHS Foundation Trust

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pulmonary Hypertension

Treatments: Other: 3-Helium gas

Study type: Interventional

Funder types: Other

Identifiers

NCT02026531

STH14070

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

3-Helium inhalation gas

Experimental group

Description:

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

Treatment:

Other: 3-Helium gas