Clinical trial NCT02388412: 18F-NaF-PET for Identification of TCFA
Official title: Evaluating the Diagnostic Accuracy of 18F-sodium Fluoride Positron Emission Tomography for Identification of High-risk Vulnerable Coronary Atherosclerotic Plaque in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: Positron emission tomography
Tissue background ratio
Optical coherence tomography
Thin cap fibroous atheroma
Vulnerability
Acute coronary syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with angina pectoris

Brief summary: 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
timeFrame: up to 1 week
Secondary outcomes:
measure: Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque
timeFrame: up to 1 week
measure: Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
timeFrame: up to 1 week
measure: Cardiac death and all-cause mortality
timeFrame: 1 year
measure: Non-fatal target vessel myocardial infarction
timeFrame: 1 year
measure: Target vessel revascularization
timeFrame: 1 year
measure: Target vessel restenosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Bon-Kwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Paeng Jin Cheol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JM, Bang JI, Koo BK, Hwang D, Park J, Zhang J, Yaliang T, Suh M, Paeng JC, Shiono Y, Kubo T, Akasaka T. Clinical Relevance of 18F-Sodium Fluoride Positron-Emission Tomography in Noninvasive Identification of High-Risk Plaque in Patients With Coronary Artery Disease. Circ Cardiovasc Imaging. 2017 Nov;10(11):e006704. doi: 10.1161/CIRCIMAGING.117.006704.