Accelerated Stress CMR in Coronary Artery Disease

NCT ID: NCT05221762

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-11-30

Brief Summary

This study will evaluate the diagnostic performance of an accelerated stress CMR protocol, comparing it with that of standard CMR assessment.

Detailed Description

This is a prospective, single-centre diagnostic accuracy study comparing the diagnostic performance of (1) accelerated and (2) standard adenosine stress CMR scans in 167 patients with suspected coronary artery disease referred for invasive coronary angiography (which will serve as the reference standard - invasive FFR).

The accelerated scan comprises accelerated cine and gadolinium imaging, with a standard stress scan (0.075mmol/kg gadolinium contrast).

Subjects will undergo both scans pre-angiography (in randomised order), enabling a head-to-head comparison of diagnostic performance (diagnostic accuracy, sensitivity and specificity) for identifying functionally significant coronary disease (as defined by fractional flow reserve <0.80).

Objectives The primary objective is to determine, in patients with suspected angina, whether the accelerated CMR protocol achieves favourable diagnostic accuracy, using invasive FFR as the reference standard, and also compared with standard CMR assessment.

Secondary objectives include comparing diagnostic performance of the accelerated CMR protocol with that of CT-FFR, a comparison of scan duration (overall and for each component - for standard and accelerated CMR), and patient tolerability and experience for each protocol (accelerated CMR, standard CMR and CTCA), as determined by a self-administered questionnaire rating patient comfort, symptoms experienced and perceived scan duration.

Data analysis

• Imaging data will be interpreted using the 16-segment American Heart Association (AHA) segmentation model
• For visual assessment of perfusion, images will be analysed by two experienced cardiologists, acting independently (differences resolved by consensus).
• For qualitative analysis, perfusion data will be analysed concurrently with late gadolinium images, with inducible ischaemia determined by the presence of a perfusion defect exceeding the area of scar.
• For quantitative analysis, myocardial blood flow (MBF) will be quantified using inline Gadgetron data (flow maps providing segmental flows).
• For qualitative analysis, ischaemia is defined as reversible hypoperfusion in two adjacent segments [32-segment model] exceeding the region of scar [if present], and for quantitative analysis, using a MBF threshold of 1.9ml/min/g.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Cardiovascular magnetic resonance (CMR)

Cardiovascular magnetic resonance (CMR) at 3 Tesla

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥18 years
• Referred for invasive coronary angiography for investigation of chest pain
• Willing and able to give informed consent
• Willing and able (in the Investigators opinion) to comply with all study requirements.
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
• Able to understand written English

Exclusion Criteria

• Recent acute coronary syndrome (< 6 months)
• Severe claustrophobia
• Absolute contraindications to CMR - those with MR conditional or safe devices will be included
• Second-/third-degree atrioventricular block
• Severe chronic obstructive pulmonary disease
• Moderate-severe asthma
• Estimated glomerular filtration rate <30 ml/min/1.73m2
• Women who are pregnant, breast-feeding or of child-bearing potential (premenopausal women)
• Contraindication to iodinated contrast
• Participants who have participated in a research study involving an investigational product in the past 12 weeks
• Patients unable to understand written English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayanth Arnold

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

Glenfield Hospital

Leicester, Leics, United Kingdom

Countries

United Kingdom

Other Identifiers

258996

Identifier Type: OTHER

Identifier Source: secondary_id

0726

Identifier Type: -

Identifier Source: org_study_id