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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06880575
Acronym
SILVER-China
Enrollment
10139
Registered
2025-03-17
Start date
2024-11-06
Completion date
2027-06-30
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arterial Disease (CAD), ELDERLY PEOPLE

Keywords

Coronary Heart Disease, Chinese Elderly, Cohort Study

Brief summary

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.

Interventions

None listed

Sponsors

Beijing Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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: 1. This admission was performed for coronary angiography, coronary artery CTA confirmed coronary heart disease; 2. Previous clear coronary angiography, coronary artery Coronary heart disease diagnosed by imaging evidence such as CTA evidence; 3. 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
major adverse cardiovascular eventsFrom enrollment to the end of follow up at 5 yearsMACCE, refers to the composite endpoint including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and ischemia-driven revascularization

Secondary

MeasureTime frameDescription
cardiogenic deathFrom enrollment to the end of follow up at 5 years
non-fatal myocardial infarctionFrom enrollment to the end of follow up at 5 years
non-fatal stroke and ischemia-driven revascularizationFrom enrollment to the end of follow up at 5 years
stent thrombosisFrom enrollment to the end of follow up at 5 years
major bleedingFrom enrollment to the end of follow up at 5 yearsBARC type 3 and 5 bleeding
all-cause mortalityFrom enrollment to the end of follow up at 5 years
NACEFrom enrollment to the end of follow up at 5 yearsMACCE and major bleeding
Quality of lifeFrom enrollment to the end of follow up at 5 yearsSmoking, alcohol consumption and nutrition were collected through questionnaires; Physical activity, sleep, and weakness were assessed by recognized scales such as the Physical Activity Scale for the Elderly (PASE), Epworth Lethargy Questionnaire, and FRAIL Weakness Scale; New York Heart Association (NYHA) cardiac function classification and Killip classification of acute myocardial infarction were used to evaluate patients' cardiac function and coronary heart disease symptoms, and Minnesota Heart Failure Quality of Life Questionnaire (MLHFQ) was used to evaluate the quality of life of patients with heart failure. The SF-36 health questionnaire was used to evaluate the overall health status and quality of life of patients.
angina pectoris readmissionFrom enrollment to the end of follow up at 5 years
heart failureFrom enrollment to the end of follow up at 5 years
all BARC bleedingFrom enrollment to the end of follow up at 5 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026