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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 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

600

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Major Adverse Cardiovascular Events (MACE)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Traditional Chinese Medicine (TCM) Syndrome Score
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Baseline
Diameter of the left ventricle at end-diastole, measured by echocardiography. Unit of Measure: mm.
Baseline
Left Ventricular End-Systolic Diameter (LVESD)
Ramy czasowe: Baseline
Diameter of the left ventricle at end-systole, measured by echocardiography. Unit of Measure: mm
Baseline
Left Ventricular Posterior Wall Thickness (LVPW)
Ramy czasowe: Baseline
Thickness of the left ventricular posterior wall in diastole, measured by echocardiography. Unit of Measure: mm.
Baseline
Interventricular Septal Thickness (IVS)
Ramy czasowe: Baseline
Thickness of the interventricular septum in diastole, measured by echocardiography. Unit of Measure: mm
Baseline
Left Ventricular Ejection Fraction (LVEF)
Ramy czasowe: Baseline
Percentage of blood ejected from the left ventricle per contraction, measured by echocardiography. Unit of Measure: %.
Baseline
Left Ventricular Fractional Shortening (FS)
Ramy czasowe: Baseline
Percentage change in left ventricular diameter between diastole and systole, measured by echocardiography. Unit of Measure: %
Baseline
E/A Ratio
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Baseline
Lowest heart rate recorded during 24-hour ambulatory ECG, with timestamp. Unit of Measure: bpm.
Baseline
Maximum Heart Rate (24-hour)
Ramy czasowe: Baseline
Highest heart rate recorded during 24-hour ambulatory ECG, with timestamp. Unit of Measure: bpm.
Baseline
Total Premature Ventricular Contractions (PVCs)
Ramy czasowe: 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)
Ramy czasowe: Baseline
Number of premature atrial contractions recorded over 24 hours by ambulatory ECG. Unit of Measure: count per 24h
Baseline
Maximum RR Interval
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Liu Qiang

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

30 czerwca 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

15 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 maja 2026

Pierwszy wysłany (Rzeczywisty)

29 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ZSLL-KY-2026-027-01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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