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

NCT06311552 | Completed

• 1 other identifier: 0856
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study

  By end of study - 30/04/2023

Study Arms (1)

CMR scan on either a 1.5- or 3-Tesla scanner

Other: Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner

Interventions

Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner OTHER

Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner

CMR scan on either a 1.5- or 3-Tesla scanner

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Either a clinical diagnosis of HFpEF, be at risk of or pre-HFpEF

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Glenfield Hospital

Leicester, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: January 31, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)