Development of Novel Physiological CMR Methods in Health and Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSheffield Teaching Hospitals NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • intravenous fluid challenge

    Other intervention

    Patients will undergo a receive a pre-load increasing stress test with intravenous fluids depending on tolerability

Treatment groups

135 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group 1Other 1 intervention
Group B: Group 2Other 1 intervention
Group C: Group 3Other 1 intervention
Group D: Group 4Other 1 intervention
Group E: Group 5Other 1 intervention
Group F: Group 6Other 1 intervention

Trial outcomes

Primary outcomes

1

4D CMR Flow

The primary outcome measures will include 4D flow CMR derived mitral inflow diastolic parameter: E/A ratio. This parameter will be quantified once both at rest and during physiological stress.

Time frame
Through study completion, average 5 years

Secondary outcomes

1

Secondary 4D CMR Flow

Other 4D flow CMR derived outcome metrics will include mitral, tricuspid and pulmonary valve flow quantification - net forward flow (mls), E-velocity (cm/sec), E-velocity deceleration time (msec, both for mitral and tricuspid), A-velocity (cm/sec) and valvular regurgitation (mls).

Time frame
Through study completion, average 5 years
2

Volumetric and functional parameters

2\) Right and left heart volumetric and functional parameters: end-diastolic and end-systolic volumes; ejection fraction

Time frame
Through study completion, average 5 years

Other outcomes

Sponsors and contacts

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