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NCT Number: NCT06880575

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

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.

Treatment and study plan

Primary outcomes

  1. major adverse cardiovascular events

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

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

Secondary outcomes

  1. all-cause mortality

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

  2. cardiogenic death

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

  3. non-fatal myocardial infarction

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

  4. non-fatal stroke and ischemia-driven revascularization

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

  5. stent thrombosis

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

  6. major bleeding

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

    BARC type 3 and 5 bleeding

  7. all BARC bleeding

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

  8. NACE

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

    MACCE and major bleeding

  9. Quality of life

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

    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.

  10. angina pectoris readmission

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

  11. heart failure

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

Sponsors and collaborators

Lead sponsor

Beijing Hospital

Other Gov

Registry information

Acronym: SILVER-China

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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