About this trial
The prevalence of congestive heart failure (CHF) in Canada is high, representing one of the health care system's most expensive diagnoses. Despite major advances in medicine, the mortality and morbidity from CHF remains great. Currently, magnetic resonance imaging (MRI) is used for non-invasive imaging of the cardiovascular system to enable the structure and anatomy of the organ to be visualized. However, current MRI methods have limitations when assessing and aiding in the management of CHF. A new imaging method has recently been developed that is showing great promise as a tool in the management of patients with CHF. Rapid imaging of biochemical reactions within myocytes using MRI has recently become possible through the use of the Dynamic Nuclear Polarization (DNP) and dissolution method. DNP-dissolution results in an intravenous contrast agent that is "hyperpolarized", producing a magnetic signal that is enhanced by up to 100,000 fold. The particular agent is carbon-13 labelled pyruvate. In this study, we demonstrate the first 13C-metabolic images of the human heart, along with the required hardware and data acquisition methods.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written consent
Age: 19 to 50 in Arm 1, 30 to 75 in Arm 2
Group 2A and 2E participants have left-ventricular hypertrophy
Group 2B and 2F participants have diagnosed hypertrophic cardiomyopathy
Disqualifiers
Contraindications to MRI or MRI contrast agents
Hemoglobin ≤ 9.0 gm/dL (only Group 2 participants)
Glomerular filtration rate (based on MDRD Equation) < 30 ml/min/1.73m2 (only Group 2 participants)
Any condition leading to a life expectancy <1 year
Trial design
Parallel
Treatments tested in this trial
Hyperpolarized (13) Pyruvate Injection
DrugMRI with Hyperpolarized Pyruvate (13) Injection
Gadolinium
DrugMRI with Gadolinium
Treatment groups
Trial outcomes
Primary outcomes
Ability of the MRI machine to produce an image of the participant's heart following an injection of Hyperpolarized Pyruvate (13C) as assessed by the physician
To demonstrate the first 13C-metabolic images of the human heart, along with the required hardware and data acquisition methods
Secondary outcomes
Imaging of participant's heart with Gadolinium
Gadolinium will be used to examine the metabolic profile in regions of scar and normal myocardium profile. LGE imaging will be performed to identify regions of scar tissue or fibrosis. LV scar will be reported as a percentage of LV mass.
Sponsors and contacts
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