Atherosclerosis Clinical Trial
— D-NaFOfficial title:
18F-Sodium Fluoride (18F-NaF) PET-CT Imaging to Identify Vulnerable Plaques in Patients With Diabetes
Verified date | May 2018 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | October 15, 2017 |
Est. primary completion date | October 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: > 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University Hospital of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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