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Идёт набор NCT05725096

Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population

Без фазы С лечением Statin Cardiovascular Risk Factors Primary Prevention Adherence, Medication

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, Traditional cardiovascular risk stratification.
Кому может быть актуально
Состояния в реестре: Statin, Cardiovascular Risk Factors, Primary Prevention, Adherence, Medication. Базовые параметры: 40 лет — 69 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

Role of the Screening with Coronary Computed Tomography Angiography on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population: a Community-based, Prospective Randomised Trial

Обзор

The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.

Подробное описание

At present, doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the RESPECT study the investigator will compare this "risk score" to coronary CTA scan. In this study the investigator would like to determine the effect of coronary CTA scan on lipid-lowering treatment and cardiovascular risk factor control.

This study will recruit 3400 eligible community volunteers (asymptomatic individuals free of any known cardiovascular event) aged 40 to 69 years, then, randomized (1:1) them to receive individualized primary prevention programs for coronary heart disease based on CCTA results or traditional risk score, as recommended in the Chinese CVD prevention guidelines. The intervention strategies in this study are consistent with RESPECT trial.

The investigator will assess the difference of lipid-lowering treatment and cardiovascular risk factor control between two groups 12 months later. Furthermore, the investigator will present the results of subclinical coronary atherosclerosis in participants who have undergone coronary CTA scans. This will help us understand the prevalence of subclinical coronary atherosclerotic disease in an asymptomatic Chinese population.

Вмешательства

  • Диагностический тест Coronary Computed Tomography Angiography
    Intervention strategies according to CCTA results
  • Другое Traditional cardiovascular risk stratification
    Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)

Первичные конечные точки

  • The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months [Срок оценки: 12 months]
Вторичные конечные точки (10)
  • The proportion of participants achieving LDL-C targets at 12 months [Срок оценки: 12 months]
  • The proportion of participants taking lipid-lowering medication regularly at 12 months. [Срок оценки: 12 months]
  • Cardiovascular events [Срок оценки: 12 months]
  • Prevalence of subclinical coronary atherosclerotic disease [Срок оценки: baseline]
  • LDL-C levels [Срок оценки: 12 months]
  • Hypertension control [Срок оценки: 12 months]
  • Diabetic control [Срок оценки: 12 months]
  • Smoking cessation [Срок оценки: 12 months]
  • Exercise [Срок оценки: 12 months]
  • Quality of life/Anxiety and Depression [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Nanjing residents who have no plans to leave in the next 5 years
  • Aged from 40 to 69 years
  • Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form

Критерии исключения

  • Serious liver dysfunction, defined as AST or ALT > 3 times the normal upper limit
  • Chronic kidney disease (CKD) > stage 4, defined as eGFR < 30 ml/min/1.73 m2
  • Prior CCTA or invasive coronary angiography within the last 5 years
  • Any contraindications for CCTA
  • Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)
  • Life expectancy < 3 years
  • Other reasons the researcher deems inappropriate to attend

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

Публикации

  • Guo X, Li J, Zhu Y, Li Y, Jiang J, Zuo R, Xu W, Ma J, Li C, Yang J, Liu Y, Zhao M, Tian D, Wang X, Sun J, Wu B, Wang C, Jiang P, Zhang J, Zhong J, Zhou C, Yi D, Bao X, Cai J, Chen Y, Cheng X, Gong H, Wei Y, Liu Y, Zhang LJ. Role of the screening with coronary computed tomography angiography on lipid management and risk factors control in an asymptomatic Chinese population: a community-based, paral PMID 39350195

Идентификаторы

NCT: NCT05725096 · 2022DZKY-056-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗