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

NCT06880575 | Recruiting DMC

• 1 other identifier: BJ-2024-140
• Study Type: observational
• Target: 10,139
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Arterial Disease (CAD); ELDERLY PEOPLE

Keywords

Coronary Heart Disease; Chinese Elderly; Cohort Study

Outcome Measures

Primary Outcomes (1)

• major adverse cardiovascular events

  MACCE, refers to the composite endpoint including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and ischemia-driven revascularization

  From enrollment to the end of follow up at 5 years

Secondary Outcomes (11)

• all-cause mortality

  From enrollment to the end of follow up at 5 years

• cardiogenic death

  From enrollment to the end of follow up at 5 years

• non-fatal myocardial infarction

  From enrollment to the end of follow up at 5 years

• non-fatal stroke and ischemia-driven revascularization

  From enrollment to the end of follow up at 5 years

• stent thrombosis

  From enrollment to the end of follow up at 5 years

Study Arms (1)

Elderly patients with coronary heart disease

1. Establish a cohort and biological sample bank of elderly patients with coronary heart disease 2. Establish a risk prediction model and clinical diagnosis and treatment optimization plan for elderly patients with coronary heart disease 3. Systematically study the multi-dimensional feature spectrum of elderly patients with coronary heart disease

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project aims to establish a nationwide cohort of elderly patients with coronary heart disease. Elderly inpatients with coronary heart disease who met the admission criteria were selected into 50 centers across the country. To ensure the representativeness of the sample, the study will adopt the following strategies: extensive coverage of different regions: select medical institutions in major geographical regions of the country to ensure geographical diversity and regional representativeness of the data; Covering different types of medical institutions ensures that patients at different levels of medical services can be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician and dean of Beijing Hospital

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 17, 2025
• Study Start: November 6, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)