Coronary Artery DiseaseNCT05221762
Accelerated Stress CMR in Coronary Artery Disease
An observational study of Coronary Artery Disease, run by University of Leicester at 1 site in United Kingdom.
Trial summary
This study will evaluate the diagnostic performance of an accelerated stress CMR protocol, comparing it with that of standard CMR assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiovascular magnetic resonance (CMR)
- How many people
- 167 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with suspected angina referred to Glenfield Hospital, Leicester, UK, for invasive coronary angiography.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accelerated Cardiovascular Magnetic Resonance 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.
Read the 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
- Being tested
- Cardiovascular magnetic resonance (CMR)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular magnetic resonance (CMR)Diagnostic test
Cardiovascular magnetic resonance (CMR) at 3 Tesla
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of accelerated CMR (qualitative assessment)
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.
Measured: 6 weeks
Diagnostic performance of accelerated CMR (quantitative assessment)
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.
Measured: 6 weeks
Secondary outcomes (14)
Sensitivity of accelerated CMR (vessel level)
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
Measured: 6 weeks
Specificity of accelerated CMR (vessel level)
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
Measured: 6 weeks
Sensitivity of accelerated CMR (patient level)
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
Measured: 6 weeks
Specificity of accelerated CMR (patient level)
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
Measured: 6 weeks
Diagnostic performance of accelerated CMR versus CTCA/FFRCT (1)
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.
Measured: 6 weeks
Diagnostic performance of accelerated CMR versus CTCA/FFRCT (2)
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.
Measured: 6 weeks
Diagnostic performance of accelerated CMR versus computed tomography coronary angiography with computed tomography-derived fractional flow reserve (CTCA/FFRCT) (2)
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.
Measured: 6 weeks
Utility of rest perfusion assessment (1)
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
Measured: 6 weeks
Utility of rest perfusion assessment (2)
Sensitivity (per vessel and per patient levels) for functionally significant coronary artery disease with a stress-only protocol compared with the stress/rest protocol
Measured: 6 weeks
Utility of rest perfusion assessment (3)
Specificity (per vessel and per patient levels) for functionally significant coronary artery disease with a stress-only protocol compared with the stress/rest protocol
Measured: 6 weeks
Subjective experience
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].
Measured: 1 week
Time duration of each scan/scan component.
Comparison of the time duration of each scan component (accelerated versus standard CMR versus CT protocols).
Measured: 1 week
Image quality
Image quality of each scan/scan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0).
Measured: 1 week
Cost analysis
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jul 2021
- Primary completion30 Jun 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Jayanth Arnold, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221762
- Sponsor's protocol ID
- 0726
- Other IDs
- 258996
- Status last verified
- Jun 2025
- First submitted
- 15 Nov 2021
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plan at the current time
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Cardiovascular Magnetic Resonance in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05221762
- Acronym / sponsor ID
- 0726
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University of Glasgow, Imperial College Healthcare NHS Trust
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with suspected angina referred to Glenfield Hospital, Leicester, UK, for invasive coronary angiography.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular magnetic resonance (CMR)Cardiovascular magnetic resonance (CMR) at 3 Tesla | Diagnostic test | – |
Primary outcome
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.
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.
14 secondary outcomes
Sensitivity of accelerated CMR (vessel level)
Time frame: 6 weeks
Specificity of accelerated CMR (vessel level)
Time frame: 6 weeks
Sensitivity of accelerated CMR (patient level)
Time frame: 6 weeks
Specificity of accelerated CMR (patient level)
Time frame: 6 weeks
Diagnostic performance of accelerated CMR versus CTCA/FFRCT (1)
Time frame: 6 weeks
Diagnostic performance of accelerated CMR versus CTCA/FFRCT (2)
Time frame: 6 weeks
Diagnostic performance of accelerated CMR versus computed tomography coronary angiography with computed tomography-derived fractional flow reserve (CTCA/FFRCT) (2)
Time frame: 6 weeks
Utility of rest perfusion assessment (1)
Time frame: 6 weeks
Utility of rest perfusion assessment (2)
Time frame: 6 weeks
Utility of rest perfusion assessment (3)
Time frame: 6 weeks
Subjective experience
Time frame: 1 week
Time duration of each scan/scan component.
Time frame: 1 week
Image quality
Time frame: 1 week
Cost analysis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Undecided. no plan at the current time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayanth Arnold principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of accelerated CMR (qualitative assessment) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.