NCT02607748

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_4 coronary-artery-disease

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

First Submitted

Initial submission to the registry

November 11, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

November 13, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

5.8 years

First QC Date

November 11, 2015

Last Update Submit

July 20, 2022

Conditions

Coronary Artery DiseaseAtherosclerotic Plaque

Keywords

18F-NaF PET18F-sodium fluoride PETCoronary CTA

Outcome Measures

Primary Outcomes (1)

  • target-to-background ratio (TBR) uptake of 18F-NaF

    a comparison of the uptake of 18F-NaF in an atherosclerotic plaque lesion compared to the background (superior vena cava)

    one day

Study Arms (1)

18F-NaF PET and coronary CTA imaging

EXPERIMENTAL

18F-NaF PET and coronary CTA imaging

Other: 18F-NaF PET and coronary CTA imaging

Interventions

18F-NaF PET and coronary CTA imagingOTHER
Also known as: 18F-NaF (sodium fluoride) PET, sodium fluoride PET, coronary CTA, CCTA, coronary CT Angiography, non-invasive coronary CT Angiography, non-invasive coronary plaque imaging
18F-NaF PET and coronary CTA imaging

Eligibility Criteria

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

You may qualify if:

  • Three groups of patients will be recruited for this study.
  • Acute Coronary Syndrome group: 40 patients with type 1 myocardial infarction within 21 days prior to the imaging visit and invasive coronary angiography with angiographic evidence of at least a 50% stenosis in one or more coronary arteries. Only patients undergoing PCI will be included in the study.
  • Stable Ischemic Heart Disease group: 40 patients who have undergone invasive coronary angiography within 21 days prior to the imaging visit, with history of typical angina prior to the angiogram, but no prior myocardial infarction or coronary revascularization.
  • Asymptomatic CAD group: 40 patients who have undergone Coronary Artery Calcium scanning within 6 months prior to the imaging visit, matched to the ACS patients for age, gender, and CAC score.
  • Patients in the asymptomatic CAD group must
  • have no prior CAD associated event (no prior myocardial infarction, acute coronary syndrome, coronary angiogram, or PCI),
  • have CAC between 10 to \<1000, and
  • match to patients in the ACS group by gender, age by decile, and CAC category (using CAC categories of 10 to \<100, 100 to \<400, 400 to \<1000).

You may not qualify if:

  • Age \< 18 years
  • Creatinine \> 1.5 mg/dL
  • History of severe allergy to Iodine contrast agents
  • Pregnancy
  • Active atrial fibrillation
  • Multiple premature ventricular or atrial contractions
  • Ejection fraction \<35%
  • Class III congestive heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseasePlaque, Atherosclerotic

Interventions

Sodium Fluoride2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Daniel S. Berman

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Nuclear Cardiology and Cardiac Imaging

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 18, 2015

Study Start

November 13, 2015

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations

US(1)