18F-NaF-PET for Identification of TCFA

Acute Coronary Syndrome Clinical Trial

— NaF-PET  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02388412
• Other study ID #: NCT7895126
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2015
• Last updated: February 21, 2016
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: February 2016
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD, PhD
• Phone: 82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque	Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque	up to 1 week	No
Secondary	Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque	Tissue-to-background ratios were calculated for each participant by dividing the maximal SUV measured in aortic valves by the mean SUV of blood in inferior vena cava	up to 1 week	No
Secondary	Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque	Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque	up to 1 week	No
Secondary	Cardiac death and all-cause mortality	Between High-TBR and Low-TBR Plaque	1 year	No
Secondary	Non-fatal target vessel myocardial infarction	Between High-TBR and Low-TBR Plaque	1 year	No
Secondary	Target vessel revascularization	Between High-TBR and Low-TBR Plaque	1 year	No
Secondary	Target vessel restenosis	Between High-TBR and Low-TBR Plaque	1 year	No