Novel MRI Techniques in the Evaluation of Pulmonary Vascu... | NCT02026531

Studies
Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

NCT02026531

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Status

Completed

Last Update Posted

Sep 30, 2015Estimated

Enrollment

9Actual

Phase

Phase 1Phase 2

Conditions

Pulmonary Hypertension

Interventions

3-Helium gas

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jun 8, 2012

First Submission Date that Met QC Criteria

Jan 2, 2014

First Posted Date

Jan 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2015

Last Update Posted Date

Sep 30, 2015Estimated

Name	Class
University of Sheffield	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3-Helium inhalation gas	Experimental	This is a pilot study. The aim is to recruit 20 patients who will all receive the product under investigation.	Other: 3-Helium gas

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3-Helium gas	Other	3-Helium gas for MRI contrast	3-Helium inhalation gas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlie Elliot, MBChB MRCP	Sheffield Teaching Hospitals NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheffield Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital		Sheffield	South Yorkshire	S10	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided