Clinical trial NCT05221762: Accelerated Stress CMR in Coronary Artery Disease
Official title: Accelerated Cardiovascular Magnetic Resonance in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: Imperial College Healthcare NHS Trust
First posted: 2022-02-03
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with suspected angina referred to Glenfield Hospital, Leicester, UK, for invasive coronary angiography.

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.

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

Primary outcomes:
measure: Diagnostic performance of accelerated CMR (qualitative assessment)
timeFrame: 6 weeks
measure: Diagnostic performance of accelerated CMR (quantitative assessment)
timeFrame: 6 weeks
Secondary outcomes:
measure: Sensitivity of accelerated CMR (vessel level)
timeFrame: 6 weeks
measure: Specificity of accelerated CMR (vessel level)
timeFrame: 6 weeks
measure: Sensitivity of accelerated CMR (patient level)
timeFrame: 6 weeks
measure: Specificity of accelerated CMR (patient level)
timeFrame: 6 weeks
measure: Diagnostic performance of accelerated CMR versus CTCA/FFRCT (1)
timeFrame: 6 weeks
measure: Diagnostic performance of accelerated CMR versus CTCA/FFRCT (2)
timeFrame: 6 weeks
measure: Diagnostic performance of accelerated CMR versus computed tomography coronary angiography with computed tomography-derived fractional flow reserve (CTCA/FFRCT) (2)
timeFrame: 6 weeks
measure: Utility of rest perfusion assessment (1)
timeFrame: 6 weeks
measure: Utility of rest perfusion assessment (2)
timeFrame: 6 weeks
measure: Utility of rest perfusion assessment (3)
timeFrame: 6 weeks
measure: Subjective experience
timeFrame: 1 week
measure: Time duration of each scan/scan component.
timeFrame: 1 week
measure: Image quality
timeFrame: 1 week
measure: Cost analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: Leics
Study officials:
affiliation: University of Leicester
name: Jayanth Arnold
role: PRINCIPAL_INVESTIGATOR
References: