Back to resultsNovel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)
Primary Purpose
Pulmonary Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring MRI, oxygen enhanced, fourier decomposition
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Pulmonary Hypertension.
- Age 18 and over.
Exclusion Criteria:
- Standard contra-indications to MRI (as per NHS MRI safety questionnaire).
- Not medically fit for transfer to MRI.
- Patient judged inappropriate for involvement in study by clinical team e.g. secondary to emotional burden of recent diagnosis.
Sites / Locations
- Royal Brompton HospitalRecruiting
Outcomes
Primary Outcome Measures
Delta pO2 max (mmHg)
Wash in and wash out time constants (min)
Signal Intensity Change (%)
Fractions (% area of lung imaged)
Secondary Outcome Measures
Full Information
NCT ID
NCT04088279
First Posted
July 31, 2019
Last Updated
September 11, 2019
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04088279
Brief Title
Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)
Official Title
Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective study of the use of two novel MRI techniques (oxygen-enhanced and fourier decomposition MRI) in the initial diagnosis and follow-up of patients with Pulmonary Hypertension. The investigators believe these techniques may present a novel set of imaging biomarkers that may be used for risk stratification, prediction of treatment response and longitudinal disease monitoring. The reserach MRI is in addition to standard of care and will not affect treatment decisions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
MRI, oxygen enhanced, fourier decomposition
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Oxygen enhanced and fourier decomposition MRI
Primary Outcome Measure Information:
Title
Delta pO2 max (mmHg)
Time Frame
Baseline and 3-6 months
Title
Wash in and wash out time constants (min)
Time Frame
Baseline and 3-6months
Title
Signal Intensity Change (%)
Time Frame
Baseline and 3-6months
Title
Fractions (% area of lung imaged)
Time Frame
Baseline and 3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of Pulmonary Hypertension.
Age 18 and over.
Exclusion Criteria:
Standard contra-indications to MRI (as per NHS MRI safety questionnaire).
Not medically fit for transfer to MRI.
Patient judged inappropriate for involvement in study by clinical team e.g. secondary to emotional burden of recent diagnosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrik Pettersson
Phone
0330 128 8736
Email
p.pettersson@rbht.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Padley
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sobi Sathianandan, MBBS
Email
s.sathianandan@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)
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