Optical Coherence Tomography in Acute Vessel Evaluation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Angiographic Guided PCI, OCT Guided PCI.
- Кому может быть актуально
- Состояния в реестре: Ischemic Heart Disease, Ischemic Coronary Artery Disease, ACS (Acute Coronary Syndrome). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия, Дания, Эстония, Финляндия, Германия +8
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Optical Coherence Tomography in Acute Vessel Evaluation (OCTAVE)
Обзор
The purpose is to investigate if a strategy of routine OCT based diagnosis and guidance of PCI improves clinical outcomes compared with a standard strategy of guidance by angiography in patients presenting with ACS
Подробное описание
Patients presenting with acute coronary syndrome (ACS) have worse short and mid-term prognosis compared with patients revascularized for chronic coronary syndrome. Angiographic assessment of patients with ACS is frequently limited by high ambiguity both in identification of culprit lesions, characterization of non-culprit lesions, and in identification of suboptimal treatment results. Intravascular imaging may improve diagnosis and allow for better treatment optimization during coronary intervention of patients with ACS. The large-scale Chinese IVUS-ACS trial showed a 50% reduction in one-year MACE with IVUS-guided PCI in patients with ACS whereas a number of small studies on routine OCT guiding as well as ACS subgroups in RCTs did not indicate a potential similar benefit with OCT. OCT assessment has several theoretical advantages over IVUS in patients with ACS indicating the need for a well-designed strategy trial on OCT vs angiographic guided PCI.
Hypothesis: Routine OCT-guided diagnosis and revascularization yields superior one-year clinical outcome compared with standard angiography-guided diagnosis and revascularization in patients with acute coronary syndrome Methods: Investigator initiated, open label, prospective, 1:1 randomized, multi-center, clinical outcome, superiority trial.
Primary Endpoint: Major adverse cardiac events (MACE) comprising all-cause death, spontaneous myocardial infarction and stroke.
Вмешательства
- Процедура Angiographic Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone - Процедура OCT Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Первичные конечные точки
- Combined endpoint of major adverse cardiac events (MACE) [Срок оценки: 12 months]
Вторичные конечные точки (12)
- Combined endpoint of major adverse cardiac events (MACE) [Срок оценки: 30 days, 36 months and 60 months]
- Patient-oriented composite (PoCE) MACE endpoint [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- All-cause mortality [Срок оценки: 30 days, 12 months, 36 months, 60 months and 10 years]
- Cardiac death [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- Spontaneous myocardial infarction [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- Any ischemia-driven revascularization [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- Any unplanned revascularization [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- Ischemia-driven target lesion revascularization [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- Ischemia-driven target vessel revascularization [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- Target lesion revascularization [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- Target vessel revascularization [Срок оценки: 30 days, 12 months, 36 months and 60 months]
- Stroke [Срок оценки: 30 days, 12 months, 36 months and 60 months]
Критерии участия
Критерии включения
Clinical inclusion criteria:
- NSTEMI, STEMI
- Symptom duration <12h for STEMI and <48h for NSTEMI
- Age ≥ 18yrs
- Ability to provide written informed consent
Angiographic inclusion criteria:
- Angiographic signs of at least one possible culprit lesion. Signs including acute occlusion, partial occlusion, proximal embolus, haziness, high grade stenosis, stent thrombosis
- Wire in true distal lumen
Критерии исключения
Clinical exclusion criteria
- Intravascular imaging evaluation of any lesions at index procedure
- Cardiogenic shock
- Sustained ventricular tachycardia or ventricular fibrillation
- Planned CABG
- Life expectancy <1 year
- Known severe heart failure with NYHA class equal or above III
- Known ejection fraction <30% before the admission
- Known renal failure with GFR <30 ml/min/1.73 m2
- Active bleeding or coagulopathy
- Relevant allergies (contrast media, aspirin, clopidogrel, ticagrelor, everolimus)
- Suspected inability to lie flat for the duration of the PCI procedure
- Inability to comply with the planned follow-up program
- Known or anticipated compliance problems with medical therapy
Angiographic exclusion criteria
- Study lesion involving the Left main coronary artery
- Study lesion involving a true bifurcation lesion with a SB >2.5mm
- Severe tortuosity
- Distal embolus
- Isolated coronary artery spasm
- Suspected spontaneous coronary artery dissection
- Chronic total occlusions with treatment indication and no antegrade intra plaque wire pass
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Дания · 5 центров
- Aalborg University Hospital — Aalborg
- Aarhus University Hospital Skejby — Aarhus N
- Rigshospitalet — København Ø
- Odense University Hospital — Odense
- Zealand University Hospital, Roskilde Sygehus — Roskilde
Швеция · 3 центра
- Sahlgrenska University Hospital — Gothenburg
- Karolinska Universitetssjukhuset — Stockholm
- Akademiske Sjukhuset — Uppsala
Германия · 2 центра
- Vivantes Klinikum im Friedrichshain — Berlin
- Universitätsklinikum Schleswig-Holstein Campus Kiel — Kiel
Норвегия · 2 центра
- Hospital of Southern Norway, Arendal — Arendal
- Akerhus University Hospital - AHUS — Lørenskog
Бельгия · 1 центр
- Leuven University Hospital — Leuven
Эстония · 1 центр
- North-Estonia Medical Centre — Tallinn
Финляндия · 1 центр
- North Karelia Central Hospital — Joensuu
Италия · 1 центр
- Turin Nord Emergency Hospital — Turin
Латвия · 1 центр
- Latvia Centre of Cardiology — Riga
Нидерланды · 1 центр
- Radboud University Medicine Center — Nijmegen
Испания · 1 центр
- Hospital Clinic de Barcelona — Barcelona
Швейцария · 1 центр
- University Hospital of Zürich — Zurich
Великобритания · 1 центр
- Royal Bournemouth Hospital — Bournemouth
Идентификаторы
NCT: NCT07422688 · OCTAVE_2025