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

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: Coronary Artery Disease; Atherosclerotic Plaque
• Intervention / Treatment: Other: 18F-NaF PET and coronary CTA imaging

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

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

Study record dates

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: 18F-NaF PET; 18F-sodium fluoride PET; Coronary CTA
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Artery Disease; Plaque, Atherosclerotic; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: 39453