NCT03530176

Brief Summary

Coronary artery calcification is a sign of heart disease. A nuclear medicine PET-CT test using sodium fluoride (18F-NaF) radioisotope has been shown to help identify growing calcification plaques early on in the disease process. It is known that diabetic patients are at a high risk of developing premature coronary disease; the investigators intend to use this new technology to identify those patients at higher risk of developing coronary artery disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

2.8 years

First QC Date

September 16, 2016

Last Update Submit

May 17, 2018

Conditions

AtherosclerosisComplications of Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 18F-Sodium Fluoride (18F-NaF) PET-CT Imaging to Identify Vulnerable Plaques in Patients With Diabetes

    Prevalence of patients with type-2 diabetes and unstable, high-risk coronary artery plaques

    4-6 weeks

Study Arms (1)

single arm

EXPERIMENTAL

18F-NaF (sodium Flouride ) is a radio-pharmaceutical used to image skeletal pathology, including primary and secondary neoplasms. Despite US Federal Drug Administration (FDA) approval and 18F-NaF being listed in the US Pharmacopeia, 18F-NaF is not currently approved by Health Canada for use as a cardiac imaging tracer. Therefore, a concurrent Health Canada Clinical Trial Application is being submitted to ensure its availability. Intervention on single arm: A dose of 18F-NaF (200 - 400 MBq) will be injected intravenously at rest. After a 60 minute, an ECG-gated PET acquisition will be performed centered over the heart for 20 minutes. A CT coronary calcium score examination will also be performed on a dedicated CT scanner and the Agatston and volume scores calculated according to standards.

Radiation: 18Fluoride-Sodium Fluoride radio-isotope

Interventions

18Fluoride-Sodium Fluoride radio-isotopeRADIATION

The investigators will be using 18F-NaF to image premature atherosclerosis in the coronary arteries of diabetic patients.

Also known as: 18F-NaF
single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years of age. Has an established diagnosis of diabetes mellitus type 1 or 2. Stable clinical course with a stable medical regimen for 6 months prior to enrollment.

You may not qualify if:

  • Unable to give consent. Weight \>250 kg. Unable to lie flat for 20-30 minutes to complete the PET-CT session. Pregnancy, breast feeding, known history of primary hyperparathyroidism or metabolic bone disease, recent malignancy (\<3 years) or previous thoracic irradiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

  • Raggi P, Senior P, Shahbaz S, Kaul P, Hung R, Coulden R, Yeung R, Abele J. 18F-Sodium Fluoride Imaging of Coronary Atherosclerosis in Ambulatory Patients With Diabetes Mellitus. Arterioscler Thromb Vasc Biol. 2019 Feb;39(2):276-284. doi: 10.1161/ATVBAHA.118.311711.

    PMID: 30580559DERIVED

MeSH Terms

Conditions

AtherosclerosisDiabetes Complications

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Paolo Raggi, MD

    Professor of Medicine, University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Chief of Cardiology, Mazankowski Alberta Heart Institute

Study Record Dates

First Submitted

September 16, 2016

First Posted

May 21, 2018

Study Start

January 1, 2015

Primary Completion

October 15, 2017

Study Completion

October 15, 2017

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)