- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02648009
Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For this study, the heart of control subjects and those with hypertension or hypertrophy will be imaged using Hyperpolarized Pyruvate 13C Injection. Different forms of Hyperpolarized Pyruvate 13C Injection are available, with the 13C labelling at different positions within the molecule. These are equivalent from a safety perspective and covered by the same Investigators Brochure, but offer different metabolic information. Two different labelling patterns are investigated in this study. If images are successfully obtained, then insights into heart failure treatments that normalize the detrimental metabolic changes may enable earlier treatment and slow disease progression to CHF, ultimately reducing the high rates of morbidity and mortality associated with this disease.
Prior to enrollment, all participants will be screened in order to ensure they meet the study's inclusion and exclusion criteria and MRI eligibility. On the day of their scan, each participant will have an intravenous line inserted and receive a glucose drink, prior to scanning. The reason for this glucose drink is that a fed versus fasted state has been found to give markedly different measurements in animal models and a choice of meal would be a source of variability. The metabolic imaging will occur shortly after this drink.
For each scan, a 1.47 g sample of [1-13C]-pyruvic acid will be hyperpolarized using a SpinLab polarizer (General Electric Co.). The solid-state sample will be dissolved to a concentration of 250 mM pyruvate at biological pH. A 0.1 mmol/kg dose (approximately 20 mL) of this solution will be injected through an intravenous line, followed by a 25 mL saline flush. The 13C image acquisition will begin at the end of the injection and will record data during every heartbeat within the single breath-hold.
Heart rate and blood pressure will be monitored non-invasively, prior to the participant being positioned within the MR scanner. Heart rate will continue to be monitored during and after the scan and the participant will be monitored by the Study's Qualified Investigator or medical designate for up to 1 hour post injection.
The 13C imaging will be preceded by the standard cardiovascular MRI workup including breath-hold cine imaging to measure ejection fraction and LV mass (~30 minutes of scan time).
Each participant in group 2 will also receive an injection of gadolinium as part of their MRI to determine evidence of late gadolinium enhancement. The recommended adult dose of 0.1ml/kg will be given. Multi-slice T1 weighted gradient echo images will be acquired. 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.
All clinical procedures will be completed under the supervision of the Qualified Investigator, or medical designate.
Each participant will receive a follow up telephone call on the 7th day following the procedure to ascertain if any study related adverse events have occurred. The length of this study for participants is a single visit that will require approximately 3 hours of their time, except for participants in Groups 1C and 1F for whom the length for the study is two visits separated by at least 2 weeks, each requiring 3 hours. The entire study is expected to take about 3 years and the results should be known approximately six months after study completion.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Nadia Bragagnolo, MSc
- Phone Number: 83655 4164806100
- Email: nadia.bragagnolo@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
-
Toronto, Ontario, Canada
- Not yet recruiting
- St. Michael's Hospital
-
Contact:
- Kim Connelly, MBBS PhD FRCP
-
Principal Investigator:
- Kim Connelly, MBBS PhD FRCP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Have received, or are scheduled to receive, another investigational medicinal product from 1 month prior to 1 month after inclusion in this study
- BMI of less than 18.5 or greater than 32
- Group 1: medically diagnosed heart disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy Volunteers
Arm 1
|
MRI with Hyperpolarized Pyruvate (13) Injection
Other Names:
|
Other: Hypertension Hypertrophy Volunteers
Arm 2
|
MRI with Hyperpolarized Pyruvate (13) Injection
Other Names:
MRI with Gadolinium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 2 years
|
To demonstrate the first 13C-metabolic images of the human heart, along with the required hardware and data acquisition methods
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging of participant's heart with Gadolinium
Time Frame: 2 years
|
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.
|
2 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 332-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Recruiting
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
Clinical Trials on Hyperpolarized (13) Pyruvate Injection
-
Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanRecruiting
-
Chang Gung Memorial HospitalNational Science and Technology CouncilNot yet recruitingCervical Cancer | Gynecologic Cancer | Ovarian Cancer | Endometrial CancerTaiwan
-
University of Texas Southwestern Medical CenterEnrolling by invitationTraumatic Brain InjuryUnited States
-
University of Texas Southwestern Medical CenterEnrolling by invitationBreast NeoplasmsUnited States
-
M.D. Anderson Cancer CenterNot yet recruiting
-
Javier Villaneuva-Meyer, MDNational Institute for Biomedical Imaging and Bioengineering (NIBIB); General...RecruitingMeningiomaUnited States
-
M.D. Anderson Cancer CenterRecruiting
-
Robert Bok, MD, PhDNational Cancer Institute (NCI); National Institute for Biomedical Imaging... and other collaboratorsRecruitingAdvanced Solid TumorUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingPrimary Brain NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer... and other conditionsUnited States