- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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).
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
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Seoul, Korea, Republiken av
- Rekrytering
- Seoul National University Hospital
-
Kontakt:
- Bon-Kwon Koo, MD, PhD
- E-post: bkkoo@snu.ac.kr
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Kontakt:
- Joo Myung Lee, MD, MPH
- E-post: drone80@hanmail.net
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Underutredare:
- Joo Myung Lee, MD, MPH
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Underutredare:
- Paeng Jin Cheol, MD, PhD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
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.
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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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
Tidsram: up to 1 week
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Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
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up to 1 week
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque
Tidsram: 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
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Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
Tidsram: up to 1 week
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Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
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up to 1 week
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Cardiac death and all-cause mortality
Tidsram: 1 year
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Between High-TBR and Low-TBR Plaque
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1 year
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Non-fatal target vessel myocardial infarction
Tidsram: 1 year
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Between High-TBR and Low-TBR Plaque
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1 year
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Target vessel revascularization
Tidsram: 1 year
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Between High-TBR and Low-TBR Plaque
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1 year
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Target vessel restenosis
Tidsram: 1 year
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Between High-TBR and Low-TBR Plaque
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1 year
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Bon-Kwon Bon-Kwon, MD, PhD, Seoul National University Hospital
- Huvudutredare: Paeng Jin Cheol, MD, PhD, Seoul National University Hospital
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCT7895126
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