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

NCT ID: NCT06880575

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10139 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-06
• Study Completion Date: 2027-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fusui Ji, MD

Chief physician and dean of Beijing Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wei Gong, M.D

Role: primary

tjmusky@126.com

86-13717676086

Tianyu Li, M.D.

Role: backup

tyli0707@fudan.edu.cn

86-18810681527

Other Identifiers

BJ-2024-140

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BJ-2024-140

Identifier Type: -

Identifier Source: org_study_id