China Elderly Comorbidity Medical Database

NCT06316544 | Recruiting DMC

• 2 other identifiers: CECMed2021ZD0111000
• Study Type: observational
• Target: 4,100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Artery Disease; Hypertension; Diabetes Mellitus; Osteoporosis; COPD Chronic Obstructive Pulmonary Disease

Keywords

elderly; Comorbidity; Chronic diseases

Outcome Measures

Primary Outcomes (20)

• Pneumonia/pulmonary infection

  1, 3, 6, 9, 12 months

• respiratory failure

  1, 3, 6, 9, 12 months

• pulmonary encephalopathy

  1, 3, 6, 9, 12 months

• acute exacerbation of chronic obstructive pulmonary disease

  1, 3, 6, 9, 12 months

• unstable angina pectoris

  1, 3, 6, 9, 12 months

• acute myocardial infarction

  1, 3, 6, 9, 12 months

• acute hemorrhagic stroke

  1, 3, 6, 9, 12 months

• acute ischemic stroke

  1, 3, 6, 9, 12 months

• acute heart failure/acute exacerbation of chronic heart failure

  1, 3, 6, 9, 12 months

• malignant ventricular arrhythmia

  1, 3, 6, 9, 12 months

• sudden death

  1, 3, 6, 9, 12 months

• falls

  1, 3, 6, 9, 12 months

• fractures

  1, 3, 6, 9, 12 months

• gastrointestinal bleeding

  1, 3, 6, 9, 12 months

• pulmonary embolism

  1, 3, 6, 9, 12 months

• deep vein thrombosis

  1, 3, 6, 9, 12 months

• diabetes ketoacidosis

  1, 3, 6, 9, 12 months

• diabetes hyperosmolar coma

  1, 3, 6, 9, 12 months

• rehospitalization

  any cause of rehospitalization

  1, 3, 6, 9, 12 months

• admission to ICU

  1, 3, 6, 9, 12 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Late stage malignant tumors, expected survival time less than 3 months;
• Completely disabled and unable to communicate;
• Unable to cooperate with follow-up.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Hypertension; Diabetes Mellitus; Osteoporosis; Pulmonary Disease, Chronic Obstructive; Chronic Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bingbing Ke, Dr

CONTACT

15510286857; 1017120710@qq.com

Wen Tang, Dr

CONTACT

15810683607; twybzx@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: March 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CN (1)