Clinical trial NCT06880575: Seniors Integrated Longitudinal cardioVascular Evaluation of Coronary Heart Disease: a Multicenter, Prospective Registry in China (SILVER-China)
Official title: Seniors Integrated Longitudinal cardioVascular Evaluation of Coronary Heart Disease: a Multicenter, Prospective Registry in China (SILVER-China)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Arterial Disease (CAD)
ELDERLY PEOPLE
Keywords: Coronary Heart Disease
Chinese Elderly
Cohort Study
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-17
Enrollment: 10139
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: From enrollment to the end of follow up at 5 years
Secondary outcomes:
measure: all-cause mortality
timeFrame: From enrollment to the end of follow up at 5 years
measure: cardiogenic death
timeFrame: From enrollment to the end of follow up at 5 years
measure: non-fatal myocardial infarction
timeFrame: From enrollment to the end of follow up at 5 years
measure: non-fatal stroke and ischemia-driven revascularization
timeFrame: From enrollment to the end of follow up at 5 years
measure: stent thrombosis
timeFrame: From enrollment to the end of follow up at 5 years
measure: major bleeding
timeFrame: From enrollment to the end of follow up at 5 years
measure: all BARC bleeding
timeFrame: From enrollment to the end of follow up at 5 years
measure: NACE
timeFrame: From enrollment to the end of follow up at 5 years
measure: Quality of life
timeFrame: From enrollment to the end of follow up at 5 years
measure: angina pectoris readmission
timeFrame: From enrollment to the end of follow up at 5 years
measure: heart failure
timeFrame: From enrollment to the end of follow up at 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References: