Accelerated Cardiovascular Magnetic Resonance in Coronary Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Leicester
- Enrollment
- 167
- Locations
- 1
- Primary Endpoint
- Diagnostic performance of accelerated CMR (qualitative assessment)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Sensitivity of accelerated CMR (vessel level)(6 weeks)
- Specificity of accelerated CMR (vessel level)(6 weeks)
- Diagnostic performance of accelerated CMR versus CTCA/FFRCT (2)(6 weeks)
- Diagnostic performance of accelerated CMR versus computed tomography coronary angiography with computed tomography-derived fractional flow reserve (CTCA/FFRCT) (2)(6 weeks)
- Utility of rest perfusion assessment (3)(6 weeks)
- Subjective experience(1 week)
- Time duration of each scan/scan component.(1 week)
- Diagnostic performance of accelerated CMR versus CTCA/FFRCT (1)(6 weeks)
- Sensitivity of accelerated CMR (patient level)(6 weeks)
- Specificity of accelerated CMR (patient level)(6 weeks)
- Utility of rest perfusion assessment (2)(6 weeks)
- Cost analysis(2 years)
- Utility of rest perfusion assessment (1)(6 weeks)
- Image quality(1 week)