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Идёт набор NCT06659367

Dedinje FFR/QFR Registry

— Наблюдательное Coronary Artery Disease (CAD) Fractional Flow Reserve

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease (CAD), Fractional Flow Reserve. 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
Сербия
Следующий шаг
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Официальное название

Institute for Cardiovascular Diseases "Dedinje" Fractional Flow Reserve (FFR) and Quantitative Flow Ratio (QFR) Registry

Обзор

Quantitative Flow Ratio (QFR) has shown good diagnostic performance against Fractional Flow Reserve (FFR) in several meta-analyses, comparable or even superior to nonhyperemic pressure ratios. However, the reproducibility of QFR is modest and there is high inter- and intra-observer variability even when fairly experienced but non-core lab operators (at least 150 QFR procedure experience) are performing the analysis. Although smaller studies have demonstrated that non-core analysis and even paramedical user analysis can have good correlation with FFR, the concern about the diagnostic performance of QFR in real-world clinical practice by inexperienced users remains. The primary objective of "Dedinje FFR/QFR Registry" is to determine the feasibility and diagnostic performance of QFR analysis by vendor-certified inexperienced medical users in a real-world setting using FFR as the gold standard. All patients \>18 years old who present to the Institute for Cardiovascular Diseases "Dedinje" and undergo a planned or ad hoc FFR procedure will be asked to participate in the registry. FFR procedure is performed according to the standardized institutional protocol. QFR analysis will be subsequently performed offline according to a standard operating procedure.

Первичные конечные точки

  • Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR) [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Sensitivity of Quantitative Flow Ratio (QFR) [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Specificity of Quantitative Flow Ratio (QFR) [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Positive predictive value of Quantitative Flow Ratio (QFR) [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Negative predictive value of Quantitative Flow Ratio (QFR) [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Diagnostic gray zone [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Diagnostic accuracy of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
Вторичные конечные точки (9)
  • Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Diagnostic accuracy of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Inter-observer variability [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Intra-observer variability [Срок оценки: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • All-cause death [Срок оценки: at 6 months, 1 year and annually for 5 years]
  • Myocardial infarction [Срок оценки: at 6 months, 1 year and annually for 5 years]
  • Vessel-oriented composite outcome [Срок оценки: at 6 months, 1 year and annually for 5 years]
  • Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months [Срок оценки: 6 months]
  • Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • >18 years old
  • Had a clinically indicated FFR procedure performed (either as a planned procedure or ad hoc)

Критерии исключения

  • Declines to participate in the registry and provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Сербия · 1 центр
  • Institute for Cardiovascular Diseases "Dedinje" — Belgrade

Идентификаторы

NCT: NCT06659367 · IRB4669

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗