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Active, Not Recruiting

NCT Number: NCT05221762

Accelerated Stress CMR in Coronary Artery Disease

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glenfield Hospital

Leicester, Leics, LE3 9QP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cardiovascular magnetic resonance (CMR)

Diagnostic Test

Cardiovascular magnetic resonance (CMR) at 3 Tesla

Primary outcomes

  1. Diagnostic performance of accelerated CMR (qualitative assessment)

    Time frame: 6 weeks

    Per vessel diagnostic accuracy of the accelerated CMR protocol (with qualitative perfusion assessment) and standard CMR protocol versus invasive coronary angiography with fractional flow reserve.

  2. Diagnostic performance of accelerated CMR (quantitative assessment)

    Time frame: 6 weeks

    Per vessel diagnostic accuracy of the accelerated CMR protocol (with quantitative perfusion assessment) and standard CMR protocol versus invasive coronary angiography with fractional flow reserve.

Secondary outcomes

  1. Sensitivity of accelerated CMR (vessel level)

    Time frame: 6 weeks

    Per vessel sensitivity of the accelerated protocol versus invasive coronary angiography with fractional flow reserve. This comparison will comprise two separate assessments of sensitivity against the reference standard - (1) algorithm with qualitative perfusion assessment (2) algorithm with quantitative perfusion assessment

  2. Specificity of accelerated CMR (vessel level)

    Time frame: 6 weeks

    Per vessel specificity of the accelerated protocol versus invasive coronary angiography with fractional flow reserve. This comparison will comprise two separate assessments of specificity against the reference standard - (1) algorithm with qualitative perfusion assessment (2) algorithm with quantitative perfusion assessment

  3. Sensitivity of accelerated CMR (patient level)

    Time frame: 6 weeks

    Per patient sensitivity of the accelerated protocol versus invasive coronary angiography with fractional flow reserve. This comparison will comprise two separate assessments of sensitivity against the reference standard - (1) algorithm with qualitative perfusion assessment (2) algorithm with quantitative perfusion assessment

  4. Specificity of accelerated CMR (patient level)

    Time frame: 6 weeks

    Per patient specificity of the accelerated protocol versus invasive coronary angiography with fractional flow reserve. This comparison will comprise two separate assessments of specificity against the reference standard - (1) algorithm with qualitative perfusion assessment (2) algorithm with quantitative perfusion assessment

  5. Diagnostic performance of accelerated CMR versus CTCA/FFRCT (1)

    Time frame: 6 weeks

    Per patient diagnostic accuracy of the accelerated CMR protocol (with qualitative perfusion assessment) for functionally significant coronary artery disease [CAD] (per patient level), compared with the diagnostic accuracy of CTCA/FFRCT.

  6. Diagnostic performance of accelerated CMR versus CTCA/FFRCT (2)

    Time frame: 6 weeks

    Per patient diagnostic accuracy of the accelerated CMR protocol (with quantitative perfusion assessment) for functionally significant CAD (per patient level), compared with the diagnostic accuracy of CTCA/FFRCT.

  7. Diagnostic performance of accelerated CMR versus computed tomography coronary angiography with computed tomography-derived fractional flow reserve (CTCA/FFRCT) (2)

    Time frame: 6 weeks

    Per patient diagnostic accuracy of the accelerated CMR protocol (with quantitative perfusion assessment) for functionally significant CAD (per patient level), compared with the diagnostic accuracy of CTCA/FFRCT.

  8. Utility of rest perfusion assessment (1)

    Time frame: 6 weeks

    Diagnostic accuracy (per vessel and per patient levels) for functionally significant coronary artery disease with a stress-only protocol compared with the stress/rest protocol

  9. Utility of rest perfusion assessment (2)

    Time frame: 6 weeks

    Sensitivity (per vessel and per patient levels) for functionally significant coronary artery disease with a stress-only protocol compared with the stress/rest protocol

  10. Utility of rest perfusion assessment (3)

    Time frame: 6 weeks

    Specificity (per vessel and per patient levels) for functionally significant coronary artery disease with a stress-only protocol compared with the stress/rest protocol

  11. Subjective experience

    Time frame: 1 week

    Comparison of 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: 4 point scale [1-4 with higher scores meaning worse outcome].

  12. Time duration of each scan/scan component.

    Time frame: 1 week

    Comparison of the time duration of each scan component (accelerated versus standard CMR versus CT protocols).

  13. Image quality

    Time frame: 1 week

    Image quality of each scan/scan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0).

  14. Cost analysis

    Time frame: 2 years

    A cost consequence and budget impact analysis will be carried out, quantifying the effects of introducing the different diagnostic strategies into the current clinical pathway. Intervention costs and associated healthcare costs will be estimated for each testing strategy. Data on resource use such as staff time, scan duration and hospital days will be collected during the study period. Relevant unit costs will be applied to estimate the total costs. Generalised linear models will be used to analyse the data with adjustments that complement the secondary analyses (above), while accounting for the nature of skewed data. Uncertainty will be estimated by calculating 95% confidence intervals through non-parametric bootstrapping. Scenario-based sensitivity analyses will also be performed and threshold analyses to characterise uncertainty.

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • Imperial College Healthcare NHS Trust
  • University of Glasgow

Registry information

Official study title

Accelerated Cardiovascular Magnetic Resonance in Coronary Artery Disease

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Feb 3, 2022
Registry last updated
Jul 2, 2025

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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