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

Heart Failure With Preserved Ejection Fraction Clinical Trial

— OPTMISE-HFpEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06311552
• Other study ID #: 0856
• Status: Completed
• Start date: January 31, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2024
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Glenfield Hospital	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study		By end of study - 30/04/2023
Secondary	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
Secondary	To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study		By end of study - 30/04/2023