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

Primary Purpose

Coronary Artery Disease, Atherosclerotic Plaque

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
18F-NaF PET and coronary CTA imaging
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring 18F-NaF PET, 18F-sodium fluoride PET, Coronary CTA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-NaF PET and coronary CTA imaging

Arm Description

18F-NaF PET and coronary CTA imaging

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
November 11, 2015
Last Updated
July 20, 2022
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02607748
Brief Title
18F-fluoride (18F-NaF) PET for Identifying Coronary Atherosclerotic Plaques
Official Title
18F-fluoride (18F-NaF) Positron Emission Tomography (PET) for Identification of Ruptured and High-Risk Coronary Atherosclerotic Plaques
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2015 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atherosclerotic Plaque
Keywords
18F-NaF PET, 18F-sodium fluoride PET, Coronary CTA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-NaF PET and coronary CTA imaging
Arm Type
Experimental
Arm Description
18F-NaF PET and coronary CTA imaging
Intervention Type
Other
Intervention Name(s)
18F-NaF PET and coronary CTA imaging
Other Intervention Name(s)
18F-NaF (sodium fluoride) PET, sodium fluoride PET, coronary CTA, CCTA, coronary CT Angiography, non-invasive coronary CT Angiography, non-invasive coronary plaque imaging
Primary Outcome Measure Information:
Title
target-to-background ratio (TBR) uptake of 18F-NaF
Description
a comparison of the uptake of 18F-NaF in an atherosclerotic plaque lesion compared to the background (superior vena cava)
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S. Berman
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

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

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