Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations. (OPTMISE-HFpEF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Other: Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom
    • Glenfield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Leicester

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 0856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No