Seniors Integrated Longitudinal cardioVascular Evaluation of Coronary Heart Disease: a Multicenter, Prospective Registry in China (SILVER-China)

Обзор

This study aims to establish a nationwide cohort and biobank of elderly patients with coronary heart disease (CHD) and to develop risk prediction models and clinical treatment optimization plans based on this data. The specific research content is as follows: The Study plan to continuously enroll hospitalized elderly CHD patients across 50 centers nationwide. Using networked electronic data collection technology, standardized methods and protocols will be used to gather demographic information (such as age, gender, education level, income, etc.), clinical information (medical history, past treatment records, current treatment plans, surgical records, medication use, etc.), lifestyle information (dietary habits, exercise frequency, smoking, drinking, etc.), biological information (such as inflammatory markers, etc.), and physical examination data (such as blood pressure, ECG, sleep monitoring, imaging examinations, etc.). These patients will be followed up long-term (1 month, 6 months, 1 year, and annually thereafter for up to 5 years) to establish a database that meets international standards. Centers meeting the criteria will also retain biological samples, creating a multicenter biobank for elderly CHD patients. Second, based on the established clinical cohort, a risk prediction model for elderly CHD patients will be developed, including mortality risk, ischemic risk, bleeding risk, etc. Additionally, optimized clinical diagnostic and treatment plans will be formulated to improve the treatment outcomes and quality of life for elderly CHD patients. This research is expected to provide scientific evidence and technical support for the prevention, diagnosis, and treatment of CHD in elderly patients.

Первичные конечные точки

• major adverse cardiovascular events [Срок оценки: From enrollment to the end of follow up at 5 years]

Вторичные конечные точки (11)

• all-cause mortality [Срок оценки: From enrollment to the end of follow up at 5 years]
• cardiogenic death [Срок оценки: From enrollment to the end of follow up at 5 years]
• non-fatal myocardial infarction [Срок оценки: From enrollment to the end of follow up at 5 years]
• non-fatal stroke and ischemia-driven revascularization [Срок оценки: From enrollment to the end of follow up at 5 years]
• stent thrombosis [Срок оценки: From enrollment to the end of follow up at 5 years]
• major bleeding [Срок оценки: From enrollment to the end of follow up at 5 years]
• all BARC bleeding [Срок оценки: From enrollment to the end of follow up at 5 years]
• NACE [Срок оценки: From enrollment to the end of follow up at 5 years]
• Quality of life [Срок оценки: From enrollment to the end of follow up at 5 years]
• angina pectoris readmission [Срок оценки: From enrollment to the end of follow up at 5 years]
• heart failure [Срок оценки: From enrollment to the end of follow up at 5 years]

Критерии участия

Критерии включения

① Age requirements: Participants are ≥ 75 years old;

• This time he was admitted to the hospital due to angina pectoris and other coronary heart disease-related symptoms

③ Conform to the diagnosis of coronary heart disease: meet any one of the following conditions:

• This admission was performed for coronary angiography, coronary artery CTA confirmed coronary heart disease;
• Previous clear coronary angiography, coronary artery Coronary heart disease diagnosed by imaging evidence such as CTA evidence;
• The attending physician according to the patient's symptoms, medical history, myocardial injury markers, electrocardiogram, echo cardiography, myocardial radionuclide imaging, etc. diagnosed coronary heart disease.

④ Informed consent: Participants must be able to understand the content of the study, voluntarily participate in the study, and sign the informed consent form.

Критерии исключения

• Combined with severe non-cardiovascular disease: life expectancy does not exceed 6 months, such as advanced cancer or other end-stage disease;
• Unable to cooperate with long-term follow-up: such as patients with severe cognitive impairment or severe mental illness; ③ Non-cardiogenic death within 24 hours after admission.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Hospital — Пекин

Идентификаторы

NCT: NCT06880575 · BJ-2024-140 · BJ-2024-140

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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