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Establishment of Disease Characteristics and a Chinese Medicine Prognosis Risk Model Based on a Large-Scale Database After Coronary Revascularization

21 мая 2026 г. обновлено: Liu Qiang
This study aims to develop a risk prediction model for patients who have undergone coronary revascularization (such as stent placement or bypass surgery). After these procedures, some patients still experience heart-related problems like chest pain, heart attack, or rehospitalization. This study will enroll 600 patients from multiple hospitals in China and follow them for 12 months. At enrollment and at 12, 24, 36, and 48 weeks after surgery, researchers will collect clinical information (including traditional Chinese medicine symptoms, blood tests, heart imaging) and biological samples (blood and tongue coating). Using artificial intelligence, the study will build a predictive model that combines Western medical data with traditional Chinese medicine characteristics. The goal is to better identify patients at higher risk of future heart events, so that personalized prevention and management can be provided. The study does not involve any experimental treatment or intervention - it is purely observational.

Обзор исследования

Статус

Еще не набирают

Условия

Подробное описание

This is a multicenter, prospective cohort study conducted at five sites in China. The study aims to develop and validate a prognostic risk model for major adverse cardiovascular events (MACE) in patients after coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting).

Study population: A total of 600 eligible patients aged ≥18 years who have undergone coronary revascularization will be enrolled consecutively. Key exclusion criteria include severe heart failure, malignant arrhythmias, severe pulmonary or liver/kidney dysfunction, pregnancy, psychiatric disorders, and poor compliance.

Data collection: At baseline (enrollment), the following data are collected: demographics, medical history, surgical characteristics (e.g., access route, number of stents, target vessels), vital signs, laboratory tests (complete blood count, cardiac enzymes, liver/kidney function, lipids, glucose), echocardiography, 24-hour ambulatory electrocardiography, and a standardized Traditional Chinese Medicine (TCM) case report form covering symptom scores, tongue/pulse findings, and pattern elements. In addition, biological samples (blood and tongue coating) are obtained for proteomics, metabolomics, and tongue-coating microbiomics.

Follow-up: Participants are followed at 12, 24, 36, and 48 weeks post-enrollment. At each follow-up, the TCM case report form is reassessed, MACE (including all-cause death, subacute stent thrombosis, perioperative myocardial infarction, recurrent myocardial infarction, recurrent unstable angina, repeat revascularization, and rehospitalization for angina or heart failure) are recorded, and NYHA functional class and current medications are updated.

Statistical analysis: Missing data will be handled by mean imputation or K-nearest neighbors imputation. Continuous variables will be standardized using Z-scores, and categorical variables will be one-hot encoded. Feature selection will be performed using LASSO regression. Three nested prediction models will be built:

  • Model_Base: Cox proportional hazards model based on routine clinical and imaging variables.
  • Model_TCM: adding TCM syndrome features using machine learning algorithms (random forest, support vector machine).
  • Model_Full: further integrating multi-omics biomarkers using deep learning methods (convolutional neural network, transformer).

Model performance will be assessed by discrimination (area under the ROC curve), calibration, and decision curve analysis. Internal validation will use k-fold cross-validation, and external validation will be conducted in at least three independent hospitals. The targeted predictive accuracy (area under the curve) is above 85%. All analyses will be performed using SPSS 26.0, Python, and R.

Ethics: The study protocol has been approved by the ethics committee of the lead site (The Third Affiliated Hospital of Zhejiang Chinese Medical University) and will be approved by participating centers. Written informed consent will be obtained from all participants.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

600

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Liu Qiang
  • Номер телефона: 13588121905
  • Электронная почта: 19981011@zcmu.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Вероятностная выборка

Исследуемая популяция

Adult patients (≥18 years) who have undergone coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) for coronary artery disease. Participants are recruited consecutively from the cardiology wards and outpatient clinics of three tertiary hospitals in China, including The Third Affiliated Hospital of Zhejiang Chinese Medical University (lead site), Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University.

Описание

Inclusion Criteria:

  • Diagnosis of coronary artery disease with prior coronary revascularization (PCI or CABG)
  • Age ≥ 18 years
  • Signed informed consent

Exclusion Criteria:

  • Malignant arrhythmias, severe heart failure, myocardial disease, or structural heart disease
  • Severe pulmonary insufficiency, severe liver or kidney dysfunction, severe electrolyte disturbances
  • Pregnancy or breastfeeding
  • Severe psychiatric disorders, malignant tumors, hematologic diseases, rheumatic immune diseases, or severe infection
  • Poor compliance or any other reason making the participant unsuitable for the study

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Adults post-coronary revascularization.
Patients aged ≥18 years who underwent coronary revascularization (PCI or CABG). Consecutive enrollment from 5 Chinese hospitals. Prospective follow-up at 12, 24, 36, and 48 weeks post-enrollment. Assessments include MACE (all-cause death, stent thrombosis, myocardial infarction, unstable angina, repeat revascularization, rehospitalization), TCM syndrome score, NYHA class, echocardiography, ambulatory ECG, and biospecimens (blood and tongue coating for proteomics, metabolomics, microbiomics). No intervention is assigned.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Major Adverse Cardiovascular Events (MACE)
Временное ограничение: 12, 24, 36, and 48 weeks post-enrollment
Composite of all-cause death, subacute stent thrombosis, perioperative myocardial infarction, recurrent myocardial infarction, recurrent unstable angina, repeat revascularization (PCI or CABG), and rehospitalization due to angina or heart failure. Events are ascertained by medical records, clinical diagnosis, coronary angiography, ECG, and cardiac enzyme/troponin measurements.
12, 24, 36, and 48 weeks post-enrollment

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Traditional Chinese Medicine (TCM) Syndrome Score
Временное ограничение: Baseline, 12, 24, 36, 48 weeks post-enrollment
Total score of TCM symptoms and signs (chest pain, palpitations, fatigue, tongue/pulse, etc.). Each item scored 0-3 (none to severe). Sum of all items. Higher score indicates more severe symptoms. Unit of Measure: points on a scale
Baseline, 12, 24, 36, 48 weeks post-enrollment
NYHA Functional Class
Временное ограничение: 12, 24, 36, 48 weeks post-enrollment
Classification of heart failure symptoms based on physical activity limitation. Class I (no limitation) to IV (symptoms at rest). Unit of Measure: relative abundance / qualitative
12, 24, 36, 48 weeks post-enrollment
Multi-omics Biomarkers (exploratory)
Временное ограничение: Baseline
Proteomics, metabolomics (LC-MS/MS, LC-MS/GC-MS) from blood, and 16S rRNA microbiome from tongue coating. Used to identify biomarkers associated with TCM patterns. Results reported as relative abundance or presence/absence. Unit of Measure: relative abundance / qualitative
Baseline
Left Ventricular End-Diastolic Diameter (LVEDD)
Временное ограничение: Baseline
Diameter of the left ventricle at end-diastole, measured by echocardiography. Unit of Measure: mm.
Baseline
Left Ventricular End-Systolic Diameter (LVESD)
Временное ограничение: Baseline
Diameter of the left ventricle at end-systole, measured by echocardiography. Unit of Measure: mm
Baseline
Left Ventricular Posterior Wall Thickness (LVPW)
Временное ограничение: Baseline
Thickness of the left ventricular posterior wall in diastole, measured by echocardiography. Unit of Measure: mm.
Baseline
Interventricular Septal Thickness (IVS)
Временное ограничение: Baseline
Thickness of the interventricular septum in diastole, measured by echocardiography. Unit of Measure: mm
Baseline
Left Ventricular Ejection Fraction (LVEF)
Временное ограничение: Baseline
Percentage of blood ejected from the left ventricle per contraction, measured by echocardiography. Unit of Measure: %.
Baseline
Left Ventricular Fractional Shortening (FS)
Временное ограничение: Baseline
Percentage change in left ventricular diameter between diastole and systole, measured by echocardiography. Unit of Measure: %
Baseline
E/A Ratio
Временное ограничение: Baseline
Ratio of early (E) to late (A) ventricular filling velocities, measured by pulsed-wave Doppler echocardiography. Unit of Measure: ratio
Baseline
Mean Heart Rate (24-hour)
Временное ограничение: Baseline
Average heart rate over 24 hours derived from ambulatory electrocardiography (Holter). Unit of Measure: beats per minute (bpm)
Baseline
Minimum Heart Rate (24-hour)
Временное ограничение: Baseline
Lowest heart rate recorded during 24-hour ambulatory ECG, with timestamp. Unit of Measure: bpm.
Baseline
Maximum Heart Rate (24-hour)
Временное ограничение: Baseline
Highest heart rate recorded during 24-hour ambulatory ECG, with timestamp. Unit of Measure: bpm.
Baseline
Total Premature Ventricular Contractions (PVCs)
Временное ограничение: Baseline
Number of premature ventricular contractions recorded over 24 hours by ambulatory ECG. Unit of Measure: count per 24h
Baseline
Total Premature Atrial Contractions (PACs)
Временное ограничение: Baseline
Number of premature atrial contractions recorded over 24 hours by ambulatory ECG. Unit of Measure: count per 24h
Baseline
Maximum RR Interval
Временное ограничение: Baseline
Longest interval between two consecutive R waves on 24-hour ambulatory ECG, indicating cardiac pause. Unit of Measure: seconds (s)
Baseline
ST Segment Depression Maximum Amplitude
Временное ограничение: Baseline
Greatest magnitude of ST segment depression during any ischemic event on 24-hour ambulatory ECG. Unit of Measure: mm (or mV)
Baseline
ST Segment Depression Longest Duration
Временное ограничение: Baseline
Longest duration of a single ST segment depression event on 24-hour ambulatory ECG. Unit of Measure: minutes (min)
Baseline
SDNN (Heart Rate Variability)
Временное ограничение: Baseline
Standard deviation of all normal-to-normal R-R intervals over 24 hours, a measure of heart rate variability. Unit of Measure: milliseconds (ms)
Baseline

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Liu Qiang

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июля 2026 г.

Первичное завершение (Оцененный)

30 июня 2028 г.

Завершение исследования (Оцененный)

31 декабря 2028 г.

Даты регистрации исследования

Первый отправленный

15 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

21 мая 2026 г.

Первый опубликованный (Действительный)

29 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • ZSLL-KY-2026-027-01

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Individual participant data (IPD) will not be shared because the informed consent obtained from participants did not include provisions for data sharing beyond the primary study. Additionally, the data contain sensitive clinical information and biospecimen-derived multi-omics data, which may raise privacy and ethical concerns. Access to de-identified data may be considered upon reasonable request to the principal investigator, subject to institutional and ethics committee approval.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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