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Ischaemic heart diseasesOther forms of heart diseasePulmonary heart disease and diseases of pulmonary circulation
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Background. An exercise heart stress test has an important role in the assessment of patients with suspected heart disease. This is mainly done by heart ultrasound test, called Echocardiography. However, Echocardiography has several limitations including poor views of the heart, especially during exercise. Using cutting-edge technology of heart MRI scans, blood flow through the heart can be seen and measured in three-dimensions (3D). This new 3D flow method is called four-dimensional flow cardiovascular magnetic resonance (4D flow CMR), where the fourth-dimension is time. Also, routine heart MRI scans for the assessment of heart’s function can now be done without breath-holds using advanced methods, allowing them to be used during exercise.
We currently don’t completely understand how heart’s function and flow interact at rest and during exercise. Therefore, there is an important need to validate these advanced heart MRI techniques to develop a better understanding of how heart adapts during exercise and importantly how this changes in heart disease.
Hence, the main aim of this study is to develop a better understanding and measure changes in 3D flow and heart’s function during exercise heart MRI scans. Also, we aim to investigate if exercise heart MRI scans offer any clinical advantage over routine heart MRI scans.
Methods. We plan to recruit 50 healthy controls and 100 patients with suspected or known heart disease who are referred for heart MRI scans. Patients will receive clinical heart MRI scans plus additional stress test imaging. Some patients will have a repeat stress heart MRI scan after treatment.
Healthy volunteers and Ppatients who have given informed consent for this research will receive one physiological stress test depending on the clinical context. There will be 5 clinical subgroups to which patients will be recruited to: Group 1. Heart failure with preserved ejection fraction (HFpEF),
Group 2. Heart failure with preserved ejection fraction (HFrEF),
Group 3. Pulmonary hypertension (PH),
Group 4. Acute myocardial infarction (AMI) and
Group 5. Suspected but not treated coronary artery disease (sCAD).
Patients will be selected in each group by the clinical specialist/research team as per the published guidelines and local protocols – Group 1 and 2 (19), Group 3 (20), Group 4 (21) and Group 5 (22).
First 4 groups of patients will receive pre-load increasing stress test (either passive leg raise, or equivalent 500mls intravenous fluid challenge depending on the tolerability). This will be done to investigate if increase in pre-load will help unravel subtle dysfunction which is not apparent at euvolemic state. AMI patients may also receive ischaemia testing stress CMR depending on the main clinically question needed to answer. Patients with sCAD will receive, clinically relevant pharmacological stress test (dobutamine, adenosine or regadenoson, inhaled nitric oxide) or magnetic resonance (MR)-compatible exercise bike test to diagnose ischaemia..
Healthy volunteers who have given informed consent will receive matched physiological stress test so that head-on comparison can be made with the relevant patient cohort. The CMR scan protocol will involve minimal breath-holds and will be patient-friendly. This is achieved by using accelerated, advanced cine and late gadolinium enhancement (LGE)-imaging techniques which require fewer breath-holds and shorter scan. All CMR stress studies will be supervised by an Advanced Life Support (ALS) certified doctor.
This study will last for 5-years to understand the long-term relevance of initial stress test.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Imaging;
You can take part if:
You may not be able to take part if:
• Exclusion Criteria • Inability to perform the study protocol secondary to severe heart failure requiring IV therapy • Patients recruited in the suspected CAD and acute myocardial infarction arms of the study and in need for detection of ischaemia should not have any past medical history of MI, ACS or cardiomyopathy • Patients with significant valvular heart disease will be excluded from any patient group • Patient with in atrial fibrillation will be excluded • Contraindication to MRI (as per standard MRI screening questionnaire issued to patients prior to clinical MRI procedures) If patient’s have severe renal failure (GFR< 30), they will not receive gadolinium-based contrast agent but still can be recruited to study.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST and funded by ACADEMY OF MEDICAL SCIENCES; University of Sheffield; .
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for Trial ID: CPMS 38460
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