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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/27/2018
Start Date:November 13, 2015
End Date:October 31, 2019
Contact:Daniel s. Berman
Email:bermand@cshs.org
Phone:310 423-4223

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Daniel S Berman, MD
Phone: 310-423-4223
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials