Trials / Completed
CompletedNCT02607748
18F-fluoride (18F-NaF) PET for Identifying Coronary Atherosclerotic Plaques
18F-fluoride (18F-NaF) Positron Emission Tomography (PET) for Identification of Ruptured and High-Risk Coronary Atherosclerotic Plaques
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Cedars-Sinai Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate whether 18F-NaF (sodium fluoride) Positron Emission Tomography (PET) scans can be used to identify ruptured and high-risk plaque as compared to non-invasive coronary Computed Tomography Angiography (CTA) scans and high-definition intravascular ultrasound (IVUS). In subsets of patients, 18F-NaF PET scans and CCTA will be repeated to assess scan-rescan reproducibility.
Detailed description
This research involves having cardiac 18F-NaF PET imaging of the heart and coronary Computed Tomographic Angiography (CTA) in a one-day visit. Three groups of patients will be enrolled: patients with Acute Coronary Syndrome, patients with stable ischemic heart disease, and asymptomatic patients with suspected coronary artery disease. Prior to 18F-NaF administration, participants will have blood drawn to measure serum creatinine and other biomarkers related to heart disease. All participants will undergo a 18F-NaF PET scan and a coronary CTA (which includes contrast administration). If medically appropriate, participants will have oral or intravenous beta-blocker (metoprolol) and nitroglycerin prior to CTA imaging. Up to 10 patients will be asked to return for repeat18F-NaF PET and coronary CTA imaging 2 to 21 days after the initial scan. Up to 20 patients will be asked to return for repeat 18F-NaF PET scan and coronary CTA imaging about 6 months after the initial scan. Researchers will compare the repeat images to the initial studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 18F-NaF PET and coronary CTA imaging |
Timeline
- Start date
- 2015-11-13
- Primary completion
- 2021-08-31
- Completion
- 2021-08-31
- First posted
- 2015-11-18
- Last updated
- 2022-07-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02607748. Inclusion in this directory is not an endorsement.