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

July 20, 2022 updated by: Daniel S. Berman, Cedars-Sinai Medical Center

18F-fluoride (18F-NaF) Positron Emission Tomography (PET) for Identification of Ruptured and High-Risk Coronary Atherosclerotic Plaques

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Three groups of patients will be recruited for this study.

  1. 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.
  2. 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.

  3. 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 18F-NaF PET and coronary CTA imaging
Other: 18F-NaF PET and coronary CTA imaging
Other Names:
  • CCTA
  • 18F-NaF (sodium fluoride) PET
  • sodium fluoride PET
  • coronary CTA
  • coronary CT Angiography
  • non-invasive coronary CT Angiography
  • non-invasive coronary plaque imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target-to-background ratio (TBR) uptake of 18F-NaF
Time Frame: one day
a comparison of the uptake of 18F-NaF in an atherosclerotic plaque lesion compared to the background (superior vena cava)
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Daniel S. Berman, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2015

Primary Completion (ACTUAL)

August 31, 2021

Study Completion (ACTUAL)

August 31, 2021

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (ESTIMATE)

November 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39453

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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