Diagnostic Accuracy in Left Ventricular Systolic Dysfunction for Identifying Coronary Artery Disease With Dobutamine Versus Adenosine Non-invasive Stress Cardiac Magnetic Resonance Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Leicester
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Presence of severe CAD (stenosis >70%) on invasive angiography and will be assessed on a per vessel basis
Study Overview
Brief Summary
This is a single centre, prospective diagnostic accuracy study to assess the comparative sensitivity of dobutamine versus adenosine for detection of severe non-infarct epicardial coronary artery stenosis in subjects with reduced LV EF ( EFed referred for clinical coronary angiography for investigation of symptoms or to establish the cause heart failure. Study participants will be identified from hospital angiography referral waiting lists, or already known with CAD and from heart failure outpatient clinics at Glenfield General Hospital. Clinical and CMR data will be collated on-site (at Glenfield General Hospital) from medical records stored and stress cardiac MRI scans at Glenfield General Hospital. The analysis will occur over a 12-month period following study commencement.
Detailed Description
Aim The primary aim of this study is to assess the comparative sensitivity of adenosine and dobutamine for detection of severe CAD in patients with HFrEF. Secondary aims are to evaluate how the addition of stress perfusion may alter management compared to CMR without stress.
Primary hypothesis:
In patients with HFrEF (EF≤40%), dobutamine perfusion has superior sensitivity to adenosine for the detection of non-infarct severe CAD (>70% epicardial coronary artery stenosis).
Secondary hypotheses The addition of stress perfusion imaging to CMR cine and LGE imaging does not significantly increase the accuracy for determining whether the aetiology of HFrEF is due to CAD or not.
The response to adenosine (haemodynamics/splenic T1) will be inversely related to markers of LV dysfunction/injury (high sensitivity troponin I/B-type natriuretic peptide) and directly to EF.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
yES
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- HFrEF (LV EF≤40%, based on either echocardiography, CMR or nuclear perfusion imaging) consistent with recent guidelines for diagnosis of HFrEF [38] referred for investigation of CAD.
- •2. Age ≥18 years ≤90 years old
- •Understand written and verbal English.
- •Patients are not involved in other research studies within the last year.
Exclusion Criteria
- •Absolute contraindication to MRI.
- •Absolute contraindication to dobutamine OR adenosine;
- •Stage III-V renal disease (estimated glomerular filtration rate <30ml/min/1.73m
- •4. Previous coronary artery bypass grafting.
- •Unstable angina or MI within 6 weeks.
- •Persistent atrial fibrillation
- •Participants who are involved in current research or have recently been involved in any research prior to recruitment
- •Participants who don't speak or understand verbal or written English
Arms & Interventions
Patients with heart failure
Patients with heart failure
Intervention: Stress Cardiac MRI (Diagnostic Test)
Outcomes
Primary Outcomes
Presence of severe CAD (stenosis >70%) on invasive angiography and will be assessed on a per vessel basis
Time Frame: 2 years
if positive
Secondary Outcomes
- Presence of inducible wall motion abnormality as a response to dobutamine by Cardiac MRI(2 years)
- Haemodynamic/splenic T1 mapping value in (ms) to adenosine by cardiac MRI scan.(2 years)
- Myocardial perfusion reserve (ml/min/g) by cardiac MRI scan.(2 years)