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Идёт набор NCT05807841

Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)

— Наблюдательное Coronary Artery Disease

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: percutaneous coronary intervention.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease. Базовые параметры: от 19 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
South Korea
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

Influence of Novel Intravascular Ultrasound-Based Artificial Intelligence Technologies on Event Reduction Following Percutaneous Coronary Intervention (INNOVATE-PCI)

Обзор

This study is a prospective, multicenter study in the real practice to validate the diagnostic performances and clinical impact of coronary angiography \& intravascular ultrasound (IVUS)-based models developed by machine learning (ML).

Подробное описание

The aim of the study is to evaluate the performances and prognostic impact of coronary angiography \& IVUS-based algorithms for decision making and stent optimization in a multicenter, prospective cohort. Between January 2020 and June 2027, a total of 3,000 patients who performed coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea. In addition, the deferred lesions with visual estimated diameter stenosis of \>30% will be evaluated as non-culprits. Brief study design is as depicted in the following figure.

Supervised ML algorithms include: 1) angiography- and IVUS-based algorithms for predicting FFR, 2) IVUS-based algorithm for plaque characterization, 3) IVUS-based algorithm for predicting stent expansion, and 4) post-stenting IVUS-based algorithm for predicting stent failure. In the prospective cohort, the performance of each model will be assessed. This registry trial composed of the treated (culprit) and the deferred (nonculprit) coronary lesions has two primary objectives as follow; 1) Primary objectives in treated (culprit) lesions is to see the impact of the integrated ML model on the development of culprit-related 2-year target vessel failure (TVF). 2) Primary objectives in deferred (nonculprit) lesions is to see the impact of the integrated ML model on the development of nonculprit-related 2-year TVF.

Вмешательства

  • Процедура percutaneous coronary intervention
    IVUS-guided stent implantation

Первичные конечные точки

  • culprit-related TVF [Срок оценки: 2 years after stent implantation]
  • nonculprit-related TVF [Срок оценки: 2 years after stent implantation]
Вторичные конечные точки (5)
  • each component of primary measures [Срок оценки: 2 years after stent implantation]
  • all cause death [Срок оценки: 2 years after stent implantation]
  • repeat revascularization [Срок оценки: 2 years after stent implantation]
  • stroke [Срок оценки: 2 years after stent implantation]
  • bleeding [Срок оценки: 2 years after stent implantation]

Критерии участия

Критерии включения

  • Age 19 years or older
  • Symptomatic angina patients with objective myocardial ischemia
  • Patients with at least one major epicardial coronary artery that requires stent implantation
  • Subject who signs with informed consent form

Patient exclusion Criteria:

  • ST-segment elevation MI at admission
  • Patients who underwent coronary artery bypass surgery or heart transplantation
  • Left ventricular ejection fraction <30%
  • Cardiogenic shock
  • Patients whose life expectancy <2 years
  • Woman who are breastfeeding, pregnant or planning to become pregnant during study
  • Patients in whom anti-platelets or heparin is contraindicated

Lesion exclusion Criteria:

  • Left main culprit lesion (angiographic diameter stenosis >50%)
  • Thrombus-containing lesion
  • In-stent restenosis
  • Side branch lesion
  • Chronic total occlusion
  • Small vessel with reference diameter <2.5mm
  • Coronary spasm despite administration of nitrate
  • Inability for imaging catheter to pass through tight stenosis, calcification, angulations
  • Poor image quality
  • Angiographically visible collateral vessels

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

South Korea · 16 центров
  • Soon Chun Hyang University Hospital Bucheon — Bucheon-si
  • Gosin University Gospel Hospital — Busan
  • Inje University Pusan Paik Hospital — Busan
  • Gyeongsang National University Changwon Hospital — Changwon
  • Kangwon National University Hospital — Chuncheon
  • Keimyung University Dongsan Medical Center — Daegu
  • The Catholic university of korea, daejeon st. mary's hospital — Daejeon
  • Gangneung Asan Hospital — Gangneung
  • … и ещё 8 центров

Идентификаторы

NCT: NCT05807841 · 2020-0226

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗