Development of Novel Physiological CMR Methods in Health and Disease
Recruiting · NCT03854071 · Interventional (participants receive a specific treatment) · Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Physiological cardiovascular stress test plays a crucial role in the assessment of patients with suspected heart disease. There are several methods of cardiac physiological stress tests and each of them offer varied insight into cardiac physiological adaptation: passive leg raise, intra-venous fluid challenge, pharmacological stressors and physical exercise stress test. Echocardiography, which is the mainstay for the non-invasive rest/stress assessment of the left ventricular (LV) haemodynamics has several limitations. Novel methods of CMR imaging allow to map intra-cardiac flow in three-dimension using novel flow acquisitions. These novel flow acquisitions are called four-dimensional flow CMR, where the fourth dimension is time. Additionally, traditional cine CMR imaging for functional assessment can now be done without breath-holds using advanced acceleration methods, allowing them to be used during exercise. A comprehensive understanding of functional-flow coupling at rest, during increased pre-load (fluid challenge) to the heart or during exercise, is lacking in the literature. There is an important need to validate these novel CMR methods for developing mechanistic insight into physiological cardiac adaptation to increased pre-load or to exercise in health and how it alters in heart disease.
Who can take part
Inclusion criteria
- Healthy Volunteers age 20 to 80, recruited from Sheffield Teaching Hospitals staff members
- Patients age 20 to 80 with suspected or known heart disease (group 1 to 5)
- Capable of giving written informed consent
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)
Where it is running
2 locations listed.
- Sheffield Teaching Hospitals NHS FT - Sheffield, England, United Kingdom
- Sheffield Teaching Hospitals NHS FT - Sheffield, England, United Kingdom