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Идёт набор NCT05743140

A Clinical Study of Fundus OCTA for the Identification of CMD

— Наблюдательное Coronary Microvascular 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: CaIMR.
Кому может быть актуально
Состояния в реестре: Coronary Microvascular Disease. 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
Китай
Следующий шаг
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Официальное название

A Clinical Study of Fundus Optical Coherence Tomography Angiography for the Identification of Coronary Microvascular Diseases

Обзор

Coronary microvascular dysfunction (CMD) carries an increased risk of adverse cardiovascular clinical outcomes. The association between fundus microcirculation changes and coronary microcirculation is not well understood. Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which can perform multi-dimensional quantitative assessment of fundus microcirculation. In this study, investigators intend to use the coronary angiography-derived index of microvascular resistance (caIMR) to screen patients with CMD, explore the relationship between relevant parameters based on OCT and OCTA measurements and caIMR, and evaluate the feasibility and clinical value of non-invasive identification of CMD through fundus OCT and OCTA.

Подробное описание

Coronary microvascular dysfunction (CMD) is defined as the clinical syndrome of angina and electrocardiographic ischemic changes in the absence of obstructive coronary artery disease. CMD carries an increased risk of adverse cardiovascular clinical outcomes. Assessment of CMD is performed with different diagnostic modalities, including nuclear myocardial scintigraphy, cardiac magnetic resonance, doppler echocardiography, and coronary microcirculation resistance index techniques. However, current examination techniques have limitations such as radiation risk, high cost, and time-consuming, so they cannot be widely screened in the population. Previous studies have shown that fundus vascular changes were strongly associated with cardiovascular events, but the correlation between fundus microcirculation changes and coronary microcirculation is not well understood. Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which use infrared light projection onto fundus tissue to achieve real-time tomographic section imaging, which can perform multi-dimensional quantitative assessment of fundus microcirculation. In this study, investigators intend to use the coronary angiography-derived index of microvascular resistance (caIMR) to screen patients with CMD, explore the relationship between relevant parameters based on OCT and OCTA measurements and caIMR, and evaluate the feasibility and clinical value of non-invasive identification of CMD through fundus OCT and OCTA.

Вмешательства

  • Диагностический тест CaIMR
    Investigators diagnose CMD with CaIMR. Investigators use OCT and OCTA to analyze the fundus microcirculation quantitatively.

Первичные конечные точки

  • Diagnostic accuracy of fundus OCT and OCTA examinations for coronary microvascular disease [Срок оценки: 2023.3-2024.5]

Критерии участия

Критерии включения

  • Patients who underwent coronary angiography in the Department of Cardiology, Peking University First Hospital;
  • Complete baseline clinical information;
  • Subject who have coronary angiography results, which shows coronary stenosis < 50%;
  • Older than 18 years;
  • Subjects who have signed informed consent.

Критерии исключения

  • Present serious fundus disease
  • Severe cataract and other ophthalmic diseases, which affect imaging quality;
  • Target coronary vessels provide collateral circulation for chronic complete occlusive lesions;
  • The target coronary angiography agent is poorly filled, overlapped, or severely distorted, and cannot fully expose the location of the lesion;
  • Coronary angiography images are of poor quality and cannot be identified;
  • Active bleeding state;
  • Severe renal insufficiency, contrast agent allergy, and unable to perform coronary angiography.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 1 центр
  • Peking university first hospital — Пекин

Идентификаторы

NCT: NCT05743140 · ZHENG Bo

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗