Last reviewed · How we verify

NCT02607748

18F-fluoride (18F-NaF) PET for Identifying Coronary Atherosclerotic Plaques

Completed Phase 4 Last updated 22 July 2022
What this trial tests

Phase 4 trial testing 18F-NaF PET and coronary CTA imaging in Coronary Artery Disease in 41 participants. Completed in 31 August 2021.

Timeline
13 November 2015
Primary endpoint
31 August 2021
31 August 2021

Quick facts

Lead sponsorCedars-Sinai Medical Center
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment41
Start date13 November 2015
Primary completion31 August 2021
Estimated completion31 August 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cedars-Sinai Medical Center

Who can join

18 and older, any sex, with Coronary Artery Disease or Atherosclerotic Plaque. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Coronary <sup>18</sup>F-Sodium Fluoride Uptake Predicts Outcomes in Patients With Coronary Artery Disease.
    Kwiecinski J, Tzolos E, Adamson PD, Cadet S, et al · · 2020 · cited 125× · PMID 32553260 · DOI 10.1016/j.jacc.2020.04.046
  2. Machine Learning with <sup>18</sup>F-Sodium Fluoride PET and Quantitative Plaque Analysis on CT Angiography for the Future Risk of Myocardial Infarction.
    Kwiecinski J, Tzolos E, Meah MN, Cadet S, et al · · 2022 · cited 47× · PMID 33893193 · DOI 10.2967/jnumed.121.262283
  3. Bypass Grafting and Native Coronary Artery Disease Activity.
    Kwiecinski J, Tzolos E, Fletcher AJ, Nash J, et al · · 2022 · cited 38× · PMID 35216930 · DOI 10.1016/j.jcmg.2021.11.030
  4. Latent Coronary Plaque Morphology From Computed Tomography Angiography, Molecular Disease Activity on Positron Emission Tomography, and Clinical Outcomes.
    Kwiecinski J, Kolossváry M, Tzolos E, Meah MN, et al · · 2023 · cited 11× · PMID 37165878 · DOI 10.1161/atvbaha.123.319332
  5. Sex differences in coronary atherosclerotic plaque activity using <sup>18</sup>F-sodium fluoride positron emission tomography.
    Kwiecinski J, Wang KL, Tzolos E, Moss A, et al · · 2024 · cited 6× · PMID 38926161 · DOI 10.1007/s00259-024-06810-x

Verify or expand the search:

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Other Cedars-Sinai Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02607748.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing