Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection
1 other identifier
interventional
112
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hypertension
Started Apr 2016
Longer than P75 for phase_1 hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
January 29, 2026
January 1, 2026
11 years
December 3, 2015
January 27, 2026
Conditions
Outcome Measures
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
2 years
Secondary Outcomes (1)
Imaging of participant's heart with Gadolinium
2 years
Study Arms (2)
Healthy Volunteers
OTHERArm 1 * Group 1A: control male volunteers between 19 and 50 years of age. * Group 1B: control female volunteers between 19 and 50 years of age. * Group 1C: control male or female volunteers between 19 and 50 years of age, with the MRI scan performed twice * Group 1D: control male volunteers between 19 and 50 years of age. * Group 1E: control female volunteers between 19 and 50 years of age. * Group 1F: control male or female volunteers between 19 and 50 years of age, with the MRI scan performed twice
Hypertension Hypertrophy Volunteers
OTHERArm 2 * Group 2A: patients aged 30 to 75 with hypertension and hypertrophy * Group 2B: patients aged 30 to 75 with non-obstructive hypertrophic cardiomyopathy (HCM). * Group 2C: stable outpatients with NYHA class 1-3 heart failure who have evidence of elevated LV mass (LVH), irrespective of LVEF. * Group 2D: stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents. * Group 2E: patients aged 30 to 75 with hypertrophy * Group 2F: patients aged 30 to 75 with hypertrophic cardiomyopathy (HCM). * Group 2G: stable outpatients with NYHA class 1-3 heart failure who have evidence of elevated LV mass (LVH), irrespective of LVEF. * Group 2H: stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents.
Interventions
MRI with Hyperpolarized Pyruvate (13) Injection
Eligibility Criteria
You may qualify if:
- 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
- Group 2C and 2G participants are stable outpatients with NYHA class 1-3 heart failure with evidence of elevated LV mass (LVH), irrespective of LVEF.
- Group 2D and 2H participants are stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents
You may not qualify if:
- 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
- Medically diagnosed claustrophobia
- BMI of less than 18.5 or greater than 32
- Group 1: medically diagnosed heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Related Publications (1)
Cunningham CH, Lau JY, Chen AP, Geraghty BJ, Perks WJ, Roifman I, Wright GA, Connelly KA. Hyperpolarized 13C Metabolic MRI of the Human Heart: Initial Experience. Circ Res. 2016 Nov 11;119(11):1177-1182. doi: 10.1161/CIRCRESAHA.116.309769. Epub 2016 Sep 15.
PMID: 27635086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Cunningham, PhD
Sunnybrook Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2015
First Posted
January 6, 2016
Study Start
April 1, 2016
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
January 29, 2026
Record last verified: 2026-01