Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart 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: Coronary Computed Tomography Angiography, Current clinical guidelines.
- Кому может быть актуально
- Состояния в реестре: Major Adverse Cardiovascular Events (MACE), Prevention, Coronary Artery Disease(CAD), CT Angiography. Базовые параметры: 18 лет — 80 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease: a Randomised Controlled Trial
Обзор
The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.
Подробное описание
Patients with non-obstructive coronary artery disease have a high rate of adverse cardiovascular events, and currently, there is still a lack of effective management strategies for these patients in clinical practice. In the SUCCESS study, investigator will compare follow-up CCTA management with routine clinical management to assess the effectiveness of follow-up CCTA in improving lipid control and reducing cardiovascular events in these patients.
The SUCCESS study is a multicenter, randomized, parallel-controlled, interventional clinical trial that recruits patients with non-obstructive coronary artery disease identified on previous CCTA (coronary artery stenosis of 20% to 70% or left main coronary artery stenosis of 20% to 50%). The experimental group is the CCTA follow-up management group, and the control group is the routine clinical follow-up management group. All participants will be randomly assigned to the experimental and control groups in a 1:1 ratio. The experimental group will undergo management using follow-up CCTA, while the control group will be managed using routine clinical and laboratory examinations. At the 1-year follow-up, all participants will undergo laboratory re-examination to observe the impact of follow-up CCTA on lipid target achievement. After 3 years of follow-up, the differences in the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) between the two groups will be compared.
Вмешательства
- Диагностический тест Coronary Computed Tomography Angiography
Based on the assessment of plaque progression after follow-up CCTA examination, patients will be given either intensive treatment or routine treatment. - Другое Current clinical guidelines
Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.
Первичные конечные точки
- Major adverse cardiovascular and cerebrovascular event [Срок оценки: 36 months after baseline]
Вторичные конечные точки (12)
- LDL-C control rate [Срок оценки: 12 months after baseline]
- Mean LDL-C changes [Срок оценки: 12 months after baseline]
- Adherence to lipid-lowering medication rate [Срок оценки: 12 months after baseline]
- The difference in healthcare-seeking rates between the two groups [Срок оценки: 12 months after baseline]
- Hypertension control rate [Срок оценки: 12 months after baseline]
- Diabetic control rate [Срок оценки: 12 months after baseline]
- Cardiac death [Срок оценки: 36 months after baseline]
- Fatal and non-fatal myocardial infarction or stroke [Срок оценки: 36 months after baseline]
- Rehospitalization due to progressive angina [Срок оценки: 36 months after baseline]
- Major adverse cardiovascular event [Срок оценки: 36 months after baseline]
- Procedures [Срок оценки: 36 months after baseline]
- Radiation dose and incidental findings from CTCA [Срок оценки: 36 months after baseline]
Критерии участия
Критерии включения
- Age between 18 and 80 years old;
- Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);
- Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.
Критерии исключения
- Patients who have experienced ACS or PCI/CABG;
- Patients who have experienced adverse cardiovascular and cerebrovascular events;
- Patients who have undergone follow-up CCTA or DSA examinations before enrollment;
- Patients with severe hepatic and renal dysfunction;
- Patients with contraindications to CCTA examinations;
- Patients with poor initial CCTA image quality or data loss.
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
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Китай · 1 центр
- Research Institute Of Medical Imaging Jinling Hospital — Нанкин
Идентификаторы
NCT: NCT06843005 · 2024DZKY-132-01