China Elderly Comorbidity Medical Database

Hypertension Clinical Trial

— CECMed  

Official title:

China Elderly Comorbidity Medical Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316544
• Other study ID #: CECMed
• Secondary ID: 2021ZD0111000
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Beijing Friendship Hospital
• Contact: Bingbing Ke, Dr
• Phone: 15510286857
• Email: 1017120710[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4100
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COPD Chronic Obstructive Pulmonary Disease
• Coronary Artery Disease
• Diabetes Mellitus
• Hypertension
• Lung Diseases, Obstructive
• Osteoporosis
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumonia/pulmonary infection		1, 3, 6, 9, 12 months
Primary	respiratory failure		1, 3, 6, 9, 12 months
Primary	pulmonary encephalopathy		1, 3, 6, 9, 12 months
Primary	acute exacerbation of chronic obstructive pulmonary disease		1, 3, 6, 9, 12 months
Primary	unstable angina pectoris		1, 3, 6, 9, 12 months
Primary	acute myocardial infarction		1, 3, 6, 9, 12 months
Primary	acute hemorrhagic stroke		1, 3, 6, 9, 12 months
Primary	acute ischemic stroke		1, 3, 6, 9, 12 months
Primary	acute heart failure/acute exacerbation of chronic heart failure		1, 3, 6, 9, 12 months
Primary	malignant ventricular arrhythmia		1, 3, 6, 9, 12 months
Primary	sudden death		1, 3, 6, 9, 12 months
Primary	falls		1, 3, 6, 9, 12 months
Primary	fractures		1, 3, 6, 9, 12 months
Primary	gastrointestinal bleeding		1, 3, 6, 9, 12 months
Primary	pulmonary embolism		1, 3, 6, 9, 12 months
Primary	deep vein thrombosis		1, 3, 6, 9, 12 months
Primary	diabetes ketoacidosis		1, 3, 6, 9, 12 months
Primary	diabetes hyperosmolar coma		1, 3, 6, 9, 12 months
Primary	rehospitalization	any cause of rehospitalization	1, 3, 6, 9, 12 months
Primary	admission to ICU		1, 3, 6, 9, 12 months