Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations.

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT06311552
• Lead Sponsor: University of Leicester

Brief Summary

The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-31
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-02
• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Males or females aged >18 years
• Either a clinical diagnosis of HFpEF, be at risk of or pre- HFpEF

Exclusion Criteria

• Absolute contraindication to MRI
• Unable to read/understand English sufficiently to provide informed consent
• Pregnancy
• Unable to consent due to lack of mental capacity
• Current cancer diagnosis and actively undergoing treatment
• Inability to exercise on the MRI ergometer
• Severe claustrophobia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper).	By end of study - 30/04/2023

Secondary Outcome Measures

Name	Time	Method
To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study	By end of study - 30/04/2023
To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study	By end of study - 30/04/2023
To determine the optimal scan acquisition protocol for Magnetic Resonance Spectroscopy (MRS) both H+ and 31P using the phosphorous coil in each patient group.	By end of study - 30/04/2023

Trial Locations

Locations (1)

Glenfield Hospital; 🇬🇧 Leicester, United Kingdom