- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02388412
18F-NaF-PET for Identification of TCFA (NaF-PET)
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
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).
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
-
-
-
Seoul, Korea, republiek van
- Werving
- Seoul National University Hospital
-
Contact:
- Bon-Kwon Koo, MD, PhD
- E-mail: bkkoo@snu.ac.kr
-
Contact:
- Joo Myung Lee, MD, MPH
- E-mail: drone80@hanmail.net
-
Onderonderzoeker:
- Joo Myung Lee, MD, MPH
-
Onderonderzoeker:
- Paeng Jin Cheol, MD, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
---|
Vulnerable plaque in optical coherence tomogrpahy
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
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
Tijdsspanne: up to 1 week
|
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
|
up to 1 week
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque
Tijdsspanne: up to 1 week
|
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
|
Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
Tijdsspanne: up to 1 week
|
Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
|
up to 1 week
|
Cardiac death and all-cause mortality
Tijdsspanne: 1 year
|
Between High-TBR and Low-TBR Plaque
|
1 year
|
Non-fatal target vessel myocardial infarction
Tijdsspanne: 1 year
|
Between High-TBR and Low-TBR Plaque
|
1 year
|
Target vessel revascularization
Tijdsspanne: 1 year
|
Between High-TBR and Low-TBR Plaque
|
1 year
|
Target vessel restenosis
Tijdsspanne: 1 year
|
Between High-TBR and Low-TBR Plaque
|
1 year
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Bon-Kwon Bon-Kwon, MD, PhD, Seoul National University Hospital
- Hoofdonderzoeker: Paeng Jin Cheol, MD, PhD, Seoul National University Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NCT7895126
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Acute kransslagader syndroom
-
Lawson Health Research InstituteVoltooidArteriosclerose van Arterial Coronary Artery Bypass GraftCanada
-
Deutsches Herzzentrum MuenchenVoltooidArteriosclerose van Arterial Coronary Artery Bypass GraftDuitsland