Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-75
SponsorSunnybrook Health Sciences Centre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hyperpolarized (13) Pyruvate Injection

    Drug

    MRI with Hyperpolarized Pyruvate (13) Injection

  • Gadolinium

    Drug

    MRI with Gadolinium

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Healthy VolunteersOther 1 intervention
Group B: Hypertension Hypertrophy VolunteersOther 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2 years

Secondary outcomes

1

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

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