Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

Pulmonary Hypertension Clinical Trial

Official title:

Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026531
• Other study ID #: STH14070
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 8, 2012
• Last updated: September 28, 2015
• Start date: November 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension
• Vascular Diseases

Intervention

Other:
• 3-Helium gas
3-Helium gas for MRI contrast

Locations

Country	Name	City	State
United Kingdom	Sheffield Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary artery diameter (mm)	Three-dimensional MRI imaging will be used to acquire cardiac dimensions and anatomical ventilation distribution as well as regional partial pressures of oxygen in the lungs.	up to 3 months	No