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Coronary Arterial Disease (CAD)SILVER-ChinaNCT06880575

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

An observational study of Coronary Arterial Disease (CAD) and ELDERLY PEOPLE, run by Beijing Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
How many people
10,139 participants
Where
1 siteChina
Study dates
6 Nov 2024to 30 Jun 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Wei Gong, M.D, 86-13717676086, tjmusky@126.com

    Tianyu Li, M.D., 86-18810681527, tyli0707@fudan.edu.cn

    Recruiting

Other trials in China

About this study

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.

Keywords
Coronary Heart Disease, Chinese Elderly, Cohort Study
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06880575
Study groupRoleWhat they receive
Elderly patients with coronary heart disease1. 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From enrollment to the end of follow up at 5 years

Secondary outcomes (11)

  1. all-cause mortality

    Measured: From enrollment to the end of follow up at 5 years

  2. cardiogenic death

    Measured: From enrollment to the end of follow up at 5 years

  3. non-fatal myocardial infarction

    Measured: From enrollment to the end of follow up at 5 years

  4. non-fatal stroke and ischemia-driven revascularization

    Measured: From enrollment to the end of follow up at 5 years

  5. stent thrombosis

    Measured: From enrollment to the end of follow up at 5 years

  6. major bleeding

    BARC type 3 and 5 bleeding

    Measured: From enrollment to the end of follow up at 5 years

  7. all BARC bleeding

    Measured: From enrollment to the end of follow up at 5 years

  8. NACE

    MACCE and major bleeding

    Measured: From enrollment to the end of follow up at 5 years

  9. Quality of life

    Smoking, 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.

    Measured: From enrollment to the end of follow up at 5 years

  10. angina pectoris readmission

    Measured: From enrollment to the end of follow up at 5 years

  11. heart failure

    Measured: From enrollment to the end of follow up at 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study start6 Nov 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,139 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06880575
Sponsor's protocol ID
BJ-2024-140
Other IDs
BJ-2024-140
Acronym
SILVER-China
Status last verified
Jan 2025
First submitted
14 Mar 2025
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Arterial Disease (CAD) and ELDERLY PEOPLE, run by Beijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

major adverse cardiovascular events (time frame: From enrollment to the end of follow up at 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06880575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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