Actively Recruiting

Phase 1
Age: 19Years - 75Years
All Genders
Healthy Volunteers
NCT02648009

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

Led by Sunnybrook Health Sciences Centre · Updated on 2026-01-29

112

Participants Needed

2

Research Sites

573 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Written consent to participate
  • Age 19 to 50 years for Arm 1 participants
  • Age 30 to 75 years for Arm 2 participants
  • Participants in Group 2A and 2E have left-ventricular hypertrophy
  • Participants in Group 2B and 2F have diagnosed hypertrophic cardiomyopathy
  • Participants in Group 2C and 2G are stable outpatients with NYHA class 1-3 heart failure and elevated left ventricular mass
  • Participants in Group 2D and 2H are stable patients with type 2 diabetes mellitus with HbA1c between 6.5% and 9% on oral hypoglycemic agents
Not Eligible

You will not qualify if you...

  • Contraindications to MRI or MRI contrast agents
  • Hemoglobin level less than or equal to 9.0 gm/dL (Group 2 only)
  • Glomerular filtration rate less than 30 ml/min/1.73m2 (Group 2 only)
  • Any condition with a life expectancy less than 1 year
  • Medically diagnosed claustrophobia
  • Use of another investigational medicinal product from 1 month before to 1 month after inclusion
  • Body mass index less than 18.5 or greater than 32
  • Medically diagnosed heart disease for Group 1 participants

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

2

St. Michael's Hospital

Toronto, Ontario, Canada

Not Yet Recruiting

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Research Team

N

Norberto Garcia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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