Coronary Artery DiseaseCECMedNCT06316544
China Elderly Comorbidity Medical Database
An observational study of Coronary Artery Disease and Hypertension, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The objective of this observational cohort study is to provide comprehensive evaluation and early warning for elderly patients with chronic diseases. The main question it aims to answer is: How to explore effective evaluation methods for diseases in elderly patients based on the coexistence of multiple diseases and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Artery Disease, Hypertension, Diabetes Mellitus
- How many people
- 4,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Nov 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The included patients are elderly (aged ≥ 65 years) patients with chronic diseases, including coronary heart disease, hypertension, diabetes, COPD, osteoporosis. One of the five common chronic diseases of the elderly, and patients who meet the diagnosis of one of the above five diseases will be include.
Who may be able to join
- Age ≥ 65 years old;
- At least one of hypertension, type 2 diabetes, coronary heart disease, osteoporosis, chronic obstructive pulmonary disease (COPD). Coronary heart disease: Heart disease caused by stenosis or occlusion of the official cavity caused by coronary atherosclerosis, resulting in myocardial ischemia, hypoxia or necrosis. This includes chronic myocardial ischemic syndrome (stable angina, ischemic cardiomyopathy, and occult coronary heart disease) and acute coronary syndrome (unstable angina and acute myocardial infarction). type 2 diabetes: HbA1c is greater than 6.5% or fasting blood glucose is greater than 126mg/dL (7.0mmol/L), and fasting is defined as no calorie intake for at least 8 hours; Or oral glucose tolerance test (OGTT) with blood glucose levels greater than 200mg/dL (11.1mmol/L) within 2 hours; Or clinical manifestations of hyperglycemia, random blood glucose greater than 200mg/dL (11.1mmol/L); Or is/has been using hypoglycemic drugs/insulin therapy. Hypertension: Twice random blood pressure, systolic blood pressure (SBP) higher than 140mmHg and/or diastolic blood pressure (DBP) higher than 90mmHg; Or is/has been taking antihypertensive medication. Chronic obstructive pulmonary disease: There are COPD related risk factors and respiratory symptoms, and lung function suggests that there is still airflow restriction after inhaling bronchodilators. The first second forced expiratory volume/forced vital capacity (FEV1/FVC) is less than 0.7. Osteoporosis: A metabolic bone disease characterized by decreased bone mass, destruction of bone tissue microstructure, increased bone fragility, and susceptibility to fractures. The diagnostic criteria are as follows: 1. A history of brittle fractures; 2. When there is no fracture, relying on dual energy X-ray absorption examination method: when measuring the axial bone density or the bone density T value of the hip or distal 1/3 of the radius is less than -2.5, it can be considered as osteoporosis.
Who cannot join
- Late stage malignant tumors, expected survival time less than 3 months;
- Completely disabled and unable to communicate;
- Unable to cooperate with follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Bingbing Ke, Dr, 15510286857, 1017120710@qq.com
Hongwei Li, Dr
About this study
The objective of this observational cohort study is to provide comprehensive evaluation and early warning for elderly patients with chronic diseases. The main question it aims to answer is: How to explore effective evaluation methods for diseases in elderly patients based on the coexistence of multiple diseases and high individual heterogeneity? How to explore the key indicators and influencing factors of adverse events in elderly patients.. Participants will be followed up at 1, 3, 6, 9, and 12 months to obtain adverse event information.
Read the detailed description
Older people represent the fastest growing sector of society and account for the largest increase in hospital admissions. They are at highest risk of acquired disability, cognitive decline, or admission to residential care, either as a consequence of illness or as an unfortunate consequence of treatment. Older people's needs are more complex with potentially coexistent medical, functional, psychological, and social needs.At the same time, comorbidities among the elderly are also extremely common, which resulting in clinical medical decision-making complex and difficult. The comorbidity rate among elderly people in the community is 76.5%; The comorbidity rate of elderly hospitalized patients can reach 91.3%. Hypertension, diabetes, coronary heart disease, COPD and osteoporosis are five common chronic diseases. Because of the intersection of risk factors, the occurrence of comorbidity is particularly obvious. In addition, frailty, malnutrition and other geriatric syndromes also seriously affect the prognosis of elderly patients with chronic diseases. The treatment plans for elderly comorbidities are often contradictory and conflicting. Medical decision-making is complex and difficult. Traditional specialized disease diagnosis and treatment benefits are limited, and the risk of iatrogenic problems is high, which further consuming medical resources. Therefore, in order to further improve the prognosis of elderly patients with chronic diseases, we established a cohort for the above five chronic disease patients, searched for risk factors for adverse events, explored effective methods for evaluating elderly patients with chronic diseases, and improved their quality of life.
- Conditions
- Coronary Artery Disease, Hypertension, Diabetes Mellitus, Osteoporosis, COPD Chronic Obstructive Pulmonary Disease
- Keywords
- elderly, Comorbidity, Chronic diseases
- Medical subject headings
- Coronary Artery Disease, Hypertension, Diabetes Mellitus, Osteoporosis, Pulmonary Disease, Chronic Obstructive, Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia/pulmonary infection
Measured: 1, 3, 6, 9, 12 months
respiratory failure
Measured: 1, 3, 6, 9, 12 months
pulmonary encephalopathy
Measured: 1, 3, 6, 9, 12 months
acute exacerbation of chronic obstructive pulmonary disease
Measured: 1, 3, 6, 9, 12 months
unstable angina pectoris
Measured: 1, 3, 6, 9, 12 months
acute myocardial infarction
Measured: 1, 3, 6, 9, 12 months
acute hemorrhagic stroke
Measured: 1, 3, 6, 9, 12 months
acute ischemic stroke
Measured: 1, 3, 6, 9, 12 months
acute heart failure/acute exacerbation of chronic heart failure
Measured: 1, 3, 6, 9, 12 months
malignant ventricular arrhythmia
Measured: 1, 3, 6, 9, 12 months
sudden death
Measured: 1, 3, 6, 9, 12 months
falls
Measured: 1, 3, 6, 9, 12 months
fractures
Measured: 1, 3, 6, 9, 12 months
gastrointestinal bleeding
Measured: 1, 3, 6, 9, 12 months
pulmonary embolism
Measured: 1, 3, 6, 9, 12 months
deep vein thrombosis
Measured: 1, 3, 6, 9, 12 months
diabetes ketoacidosis
Measured: 1, 3, 6, 9, 12 months
diabetes hyperosmolar coma
Measured: 1, 3, 6, 9, 12 months
rehospitalization
any cause of rehospitalization
Measured: 1, 3, 6, 9, 12 months
admission to ICU
Measured: 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Mar 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 4,100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Principal investigator, Hongwei Li, MD, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316544
- Sponsor's protocol ID
- CECMed
- Other IDs
- 2021ZD0111000
- Acronym
- CECMed
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu Y, Tang W, Yang H, Niu J, Dou L, Gu Y, Wu Y, Zhang W, Sun Y, Yang X. The potential of LLMs in generating questions and answers with EHRs. Front Digit Health. 2026 Jul 15;8:1799629. doi: 10.3389/fdgth.2026.1799629. eCollection 2026.
PubMed 42529250
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Elderly Comorbidity Medical Database
- ClinicalTrials.gov ID
- NCT06316544
- Acronym / sponsor ID
- CECMed / CECMed
- Conditions
- Coronary Artery Disease, Hypertension, Diabetes Mellitus, Osteoporosis, COPD Chronic Obstructive Pulmonary Disease
- Keywords
- elderly, Comorbidity, Chronic diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this observational cohort study is to provide comprehensive evaluation and early warning for elderly patients with chronic diseases. The main question it aims to answer is: How to explore effective evaluation methods for diseases in elderly patients based on the coexistence of multiple diseases and high individual heterogeneity? How to explore the key indicators and influencing factors of adverse events in elderly patients.. Participants will be followed up at 1, 3, 6, 9, and 12 months to obtain adverse event information.
Detailed description
Older people represent the fastest growing sector of society and account for the largest increase in hospital admissions. They are at highest risk of acquired disability, cognitive decline, or admission to residential care, either as a consequence of illness or as an unfortunate consequence of treatment. Older people's needs are more complex with potentially coexistent medical, functional, psychological, and social needs.At the same time, comorbidities among the elderly are also extremely common, which resulting in clinical medical decision-making complex and difficult. The comorbidity rate among elderly people in the community is 76.5%; The comorbidity rate of elderly hospitalized patients can reach 91.3%. Hypertension, diabetes, coronary heart disease, COPD and osteoporosis are five common chronic diseases. Because of the intersection of risk factors, the occurrence of comorbidity is particularly obvious. In addition, frailty, malnutrition and other geriatric syndromes also seriously affect the prognosis of elderly patients with chronic diseases. The treatment plans for elderly comorbidities are often contradictory and conflicting. Medical decision-making is complex and difficult. Traditional specialized disease diagnosis and treatment benefits are limited, and the risk of iatrogenic problems is high, which further consuming medical resources. Therefore, in order to further improve the prognosis of elderly patients with chronic diseases, we established a cohort for the above five chronic disease patients, searched for risk factors for adverse events, explored effective methods for evaluating elderly patients with chronic diseases, and improved their quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The included patients are elderly (aged ≥ 65 years) patients with chronic diseases, including coronary heart disease, hypertension, diabetes, COPD, osteoporosis. One of the five common chronic diseases of the elderly, and patients who meet the diagnosis of one of the above five diseases will be include.
Key inclusion criteria (2 listed)
- Age ≥ 65 years old;
- At least one of hypertension, type 2 diabetes, coronary heart disease, osteoporosis, chronic obstructive pulmonary disease (COPD). Coronary heart disease: Heart disease caused by stenosis or occlusion of the official cavity caused by coronary atherosclerosis, resulting in myocardial ischemia, hypoxia or necrosis. This includes chronic myocardial ischemic syndrome (stable angina, ischemic cardiomyopathy, and occult coronary heart disease) and acute coronary syndrome (unstable angina and acute myocardial infarction). type 2 diabetes: HbA1c is greater than 6.5% or fasting blood glucose is greater than 126mg/dL (7.0mmol/L), and fasting is defined as no calorie intake for at least 8 hours; Or oral glucose tolerance test (OGTT) with blood glucose levels greater than 200mg/dL (11.1mmol/L) within 2 hours; Or clinical manifestations of hyperglycemia, random blood glucose greater than 200mg/dL (11.1mmol/L); Or is/has been using hypoglycemic drugs/insulin therapy. Hypertension: Twice random blood pressure, systolic blood pressure (SBP) higher than 140mmHg and/or diastolic blood pressure (DBP) higher than 90mmHg; Or is/has been taking antihypertensive medication. Chronic obstructive pulmonary disease: There are COPD related risk factors and respiratory symptoms, and lung function suggests that there is still airflow restriction after inhaling bronchodilators. The first second forced expiratory volume/forced vital capacity (FEV1/FVC) is less than 0.7. Osteoporosis: A metabolic bone disease characterized by decreased bone mass, destruction of bone tissue microstructure, increased bone fragility, and susceptibility to fractures. The diagnostic criteria are as follows: 1. A history of brittle fractures; 2. When there is no fracture, relying on dual energy X-ray absorption examination method: when measuring the axial bone density or the bone density T value of the hip or distal 1/3 of the radius is less than -2.5, it can be considered as osteoporosis.
Key exclusion criteria (3 listed)
- Late stage malignant tumors, expected survival time less than 3 months;
- Completely disabled and unable to communicate;
- Unable to cooperate with follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pneumonia/pulmonary infection
Time frame: 1, 3, 6, 9, 12 months
respiratory failure
Time frame: 1, 3, 6, 9, 12 months
pulmonary encephalopathy
Time frame: 1, 3, 6, 9, 12 months
acute exacerbation of chronic obstructive pulmonary disease
Time frame: 1, 3, 6, 9, 12 months
unstable angina pectoris
Time frame: 1, 3, 6, 9, 12 months
acute myocardial infarction
Time frame: 1, 3, 6, 9, 12 months
acute hemorrhagic stroke
Time frame: 1, 3, 6, 9, 12 months
acute ischemic stroke
Time frame: 1, 3, 6, 9, 12 months
acute heart failure/acute exacerbation of chronic heart failure
Time frame: 1, 3, 6, 9, 12 months
malignant ventricular arrhythmia
Time frame: 1, 3, 6, 9, 12 months
sudden death
Time frame: 1, 3, 6, 9, 12 months
falls
Time frame: 1, 3, 6, 9, 12 months
fractures
Time frame: 1, 3, 6, 9, 12 months
gastrointestinal bleeding
Time frame: 1, 3, 6, 9, 12 months
pulmonary embolism
Time frame: 1, 3, 6, 9, 12 months
deep vein thrombosis
Time frame: 1, 3, 6, 9, 12 months
diabetes ketoacidosis
Time frame: 1, 3, 6, 9, 12 months
diabetes hyperosmolar coma
Time frame: 1, 3, 6, 9, 12 months
rehospitalization
Time frame: 1, 3, 6, 9, 12 months
any cause of rehospitalization
admission to ICU
Time frame: 1, 3, 6, 9, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 42529250Zhu Y, Tang W, Yang H, Niu J, Dou L, Gu Y, Wu Y, Zhang W, Sun Y, Yang X. The potential of LLMs in generating questions and answers with EHRs. Front Digit Health. 2026 Jul 15;8:1799629. doi: 10.3389/fdgth.2026.1799629. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Hypertension, run by Beijing Friendship 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingbing Ke, Dr (15510286857, 1017120710@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia/pulmonary infection (time frame: 1, 3, 6, 9, 12 months). The study lists 20 primary outcomes in all. 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 NCT06316544, which also lists 1 linked publication.
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 19 Mar 2024.