18F-NaF-PET for Identification of TCFA

Seoul National University

Status: Unknown

Conditions: Acute Coronary Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT02388412

NCT7895126

Details and patient eligibility

About

Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies.

In this study, the investigators will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).

Full description

It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Until now, evaluation of vulnerable plaque have been mainly performed with invasive imaging modalities such as optical coherence tomography or intravascular ultrasound.

Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies.

In this study, we will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).

Enrollment: 96 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
• 2. Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by coronary CT angiography.
• 3. Patients who are anticipated coronary artery disease.(Probability > 90 %)
• 4. Acute coronary syndrome.

Exclusion criteria

• 1. Stenosis at distal coronary or small vessel.
• 2. Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
• 3. Inadequate quality of 18F-NaF PET-CT
• 4. Inadequate quality of Optical Coherence Tomography (OCT), IVUS, Coronary CT angiography

Trial design

96 participants in 2 patient groups

Vulnerable plaque in optical coherence tomogrpahy

Description:

OCT-derived vulnerable plaque is defined as composite of thin-cap fibrous atheroma (cap thickness in optical coherence tomography \< 60um), prominent macrophage, or prominent microvessels.

Non-vulnerable plaque in Optical coherence tomogrpahy

Description:

OCT-derived vulnerable plaque is defined as composite of thin-cap fibrous atheroma (cap thickness in optical coherence tomography \< 60um), prominent macrophage, or prominent microvessels. OCT-derived non-vulnerable plaque is defined as a plaque without any of the findings