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OpenTrials
Completed

NCT Number: NCT06311552

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

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Glenfield Hospital

Leicester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper).

    Time frame: By end of study - 30/04/2023

Secondary outcomes

  1. To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study

    Time frame: By end of study - 30/04/2023

  2. To determine the optimal scan acquisition protocol for Magnetic Resonance Spectroscopy (MRS) both H+ and 31P using the phosphorous coil in each patient group.

    Time frame: By end of study - 30/04/2023

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

    Time frame: By end of study - 30/04/2023

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Registry information

Acronym: OPTMISE-HFpEF

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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