Back to resultsNovel MRI Techniques in the Evaluation of Pulmonary Vascular Disease
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
3-Helium gas
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension
Eligibility Criteria
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
Sites / Locations
- Sheffield Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3-Helium inhalation gas
Arm Description
This is a pilot study. The aim is to recruit 20 patients who will all receive the product under investigation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02026531
First Posted
June 8, 2012
Last Updated
September 28, 2015
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT02026531
Brief Title
Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease
Official Title
Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3-Helium inhalation gas
Arm Type
Experimental
Arm Description
This is a pilot study. The aim is to recruit 20 patients who will all receive the product under investigation.
Intervention Type
Other
Intervention Name(s)
3-Helium gas
Intervention Description
3-Helium gas for MRI contrast
Primary Outcome Measure Information:
Title
pulmonary artery diameter (mm)
Description
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.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlie Elliot, MBChB MRCP
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease
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