Construction of a Comprehensive Health Management Platform for Patients With Cardiovascular-Kidney-Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Height
研究概览
简要总结
Cardiovascular-Kidney-Metabolic (CKM) syndrome underscores the pathophysiologic interplay among metabolic risk factors, chronic kidney disease (CKD) and the cardiovascular system. This crosstalk precipitates multi-organ dysfunction, increases adverse cardiovascular events, and imposes heavy familial and socioeconomic burdens. Building a health-management platform within research wards is therefore urgent. Such a platform is the pivotal venue for assessment, monitoring, intervention and follow-up in continuous care.
Leveraging the existing health-management system of the Health Screening Center at Peking University Third Hospital, the investigators will develop a comprehensive CKM platform that integrates systemic inflammatory biomarkers, cardiovascular early-warning algorithms, and personalized diet-and-exercise prescriptions. The system will provide cyclic management encompassing evaluation, guidance, monitoring, feedback and longitudinal follow-up.
A randomized controlled trial with two-year prospective follow-up will enroll patients at CKM stages 0-2 to evaluate clinical improvement, quality of life, dietary behavior and physical activity after platform enrollment. The project will enable early identification of high-risk individuals, deliver precision management, maximize data utility, and offer a novel research-ward model that addresses mobile-health pain points and closes the CKM care loop.
详细描述
1.Construction of a Comprehensive CKM Health-Management Platform
- Needs analysis & user research: Drawing on parallel work on CKM inflammatory biomarkers, cardiovascular early-warning algorithms and personalised exercise prescriptions, the investigators will use literature review, focus groups and expert panels to elicit needs of CKM patients and clinicians. The platform will provide screening, assessment, intervention and longitudinal follow-up-e.g. individual exercise/diet plans, tele-consultation and data analytics.
- Data integration & governance: Health data from electronic health records, laboratory reports and wearables will be unified. Privacy, security and regulatory compliance will be ensured.
- Remote monitoring & online consultation: Real-time monitoring and tele-consultation will improve access. Issues such as network latency, data security and service quality will be addressed.
2. Deployment and feasibility evaluation CKM stage 0-2 patients meeting diagnostic criteria will receive two-year comprehensive management via the platform. Clinical metrics and quality-of-life indices will be used to evaluate feasibility, early identification of high-risk individuals, improvement of composite CKM endpoints and patient-centred outcomes.
3. Innovation highlights This project will deliver the first Chinese integrated health-information platform dedicated to CKM syndrome. It unites systemic inflammatory biomarkers, cardiovascular (early-warning) algorithms and individualised diet/exercise modules into one (closed-loop) system that continuously monitors, profiles, analyses, risk-stratifies, manages and follows each patient. Multi-dimensional data (physiology, lifestyle, genetics) feed an individualised management cycle of "monitor-profile-analyse-risk-score-intervene-follow-up", offering a novel methodologic and theoretical framework for early risk detection and precision intervention in CKM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKM stage 0-2 as defined by the American Heart Association CKM diagnostic guidelines
- •Age 18-75 years
- •Able to use a smartphone and wearable activity tracker
- •Willing to sign informed consent and attend scheduled follow-up visits
排除标准
- •CKM stage 3-4
- •Acute or critically ill conditions requiring hospitalization
- •Malignant tumors or any active cancer under treatment
研究组 & 干预措施
Experimental Arm
Enrolled into a comprehensive health-management platform for cardiorenal metabolic syndrome and received integrated management for 2 years.
干预措施: Comprehensive Health Management Platform (Behavioral)
Control Arm
The control group receives routine post-examination follow-up and health management provided by the health check-up center.
干预措施: Post-examination follow-up management (Other)
结局指标
主要结局
Height
时间窗: Baseline, Month 12, Month 24
Body height measured in centimeters using a height and weight measuring instrument. Reported as mean value at each assessment time point.
Weight
时间窗: Baseline, Month 12, Month 24
Body weight measured in kilograms using a height and weight measuring instrument. Reported as mean value at each assessment time point.
Systolic Blood Pressure
时间窗: Baseline, Month 12, Month 24
Systolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point.
Diastolic Blood Pressure
时间窗: Baseline, Month 12, Month 24
Diastolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point.
Heart Rate on 12-Lead Electrocardiogram
时间窗: Baseline, Month 12, Month 24
Heart rate measured in beats per minute (bpm) from 12-lead electrocardiogram recorded after 10 minutes of rest in supine position. Reported as mean value at each assessment time point.
PR Interval on 12-Lead Electrocardiogram
时间窗: Baseline, Month 12, Month 24
PR interval measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point.
QRS Duration on 12-Lead Electrocardiogram
时间窗: Baseline, Month 12, Month 24
QRS duration measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point.
QTc Interval on 12-Lead Electrocardiogram
时间窗: Baseline, Month 12, Month 24
Corrected QT interval (QTc) measured in milliseconds (ms) using Bazett's formula from 12-lead electrocardiogram. Reported as mean value at each assessment time point.
Left Ventricular Ejection Fraction (LVEF)
时间窗: Baseline, Month 12, Month 24
Left ventricular ejection fraction measured as percentage (%) using two-dimensional echocardiography with Simpson's biplane method. Higher values indicate better cardiac function. Reported as mean value at each assessment time point.
Left Ventricular End-Diastolic Diameter (LVEDD)
时间窗: Baseline, Month 12, Month 24
Left ventricular end-diastolic diameter measured in millimeters (mm) using M-mode echocardiography. Reported as mean value at each assessment time point.
Concentration of Lactate Dehydrogenase (LDH)
时间窗: Baseline, Month 12, Month 24
Serum lactate dehydrogenase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
Concentration of Alpha-Hydroxybutyrate Dehydrogenase (α-HBDH)
时间窗: Baseline, Month 12, Month 24
Serum alpha-hydroxybutyrate dehydrogenase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value at each assessment time point.
Concentration of Creatine Kinase (CK)
时间窗: Baseline, Month 12, Month 24
Serum creatine kinase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
Concentration of Creatine Kinase-MB (CK-MB)
时间窗: Baseline, Month 12, Month 24
Serum creatine kinase-MB isoenzyme activity measured in units per liter (U/L) using immunoinhibition assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
Urine Occult Blood
时间窗: Baseline, Month 12, Month 24
Presence of occult blood in urine detected using dipstick method. Reported as number and percentage of participants with positive result (1+ or greater) at each assessment time point.
Urine Protein
时间窗: Baseline, Month 12, Month 24
Presence of protein in urine detected using dipstick method. Reported as number and percentage of participants with positive result (1+ or greater) at each assessment time point.
Concentration of Total Bilirubin
时间窗: Baseline, Month 12, Month 24
Serum total bilirubin concentration measured in micromoles per liter (μmol/L) using diazo method. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
Concentration of Total Protein
时间窗: Baseline, Month 12, Month 24
Serum total protein concentration measured in grams per liter (g/L) using biuret method. Reported as mean value at each assessment time point.
Concentration of Albumin
时间窗: Baseline, Month 12, Month 24
Serum albumin concentration measured in grams per liter (g/L) using bromocresol green method. Reported as mean value and number of participants with values below lower limit of normal (LLN) at each assessment time point.
Concentration of Direct Bilirubin
时间窗: Baseline, Month 12, Month 24
Serum direct (conjugated) bilirubin concentration measured in micromoles per liter (μmol/L) using diazo method with caffeine accelerator. Reported as mean value at each assessment time point.
Activity of Aspartate Aminotransferase (AST)
时间窗: Baseline, Month 12, Month 24
Serum aspartate aminotransferase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
Activity of Alanine Aminotransferase (ALT)
时间窗: Baseline, Month 12, Month 24
Serum alanine aminotransferase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
Concentration of Globulin
时间窗: Baseline, Month 12, Month 24
Serum globulin concentration calculated as the difference between total protein and albumin concentrations, measured in grams per liter (g/L). Reported as mean value at each assessment time point.
Concentration of Uric Acid
时间窗: Baseline, Month 12, Month 24
Serum uric acid concentration measured in micromoles per liter (μmol/L) using uricase method. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
Estimated Glomerular Filtration Rate (eGFR)
时间窗: Baseline, Month 12, Month 24
Estimated glomerular filtration rate calculated in milliliters per minute per 1.73 square meters (mL/min/1.73m²) using CKD-EPI equation based on serum creatinine and cystatin C. Higher values indicate better kidney function. Reported as mean value and number of participants with eGFR \<60 mL/min/1.73m² at each assessment time point.
Concentration of Total Cholesterol
时间窗: Baseline, Month 12, Month 24
Serum total cholesterol concentration measured in millimoles per liter (mmol/L) using enzymatic colorimetric assay after overnight fasting. Reported as mean value at each assessment time point.
Concentration of Triglycerides
时间窗: Baseline, Month 12, Month 24
Serum triglyceride concentration measured in millimoles per liter (mmol/L) using enzymatic glycerol phosphate oxidase method after overnight fasting. Reported as mean value at each assessment time point.
Concentration of Low-Density Lipoprotein Cholesterol (LDL-C)
时间窗: Baseline, Month 12, Month 24
Serum LDL-C concentration measured in millimoles per liter (mmol/L) using direct enzymatic assay or calculated using Friedewald formula after overnight fasting. Lower values indicate better cardiovascular risk profile. Reported as mean value at each assessment time point.
Concentration of High-Density Lipoprotein Cholesterol (HDL-C)
时间窗: Baseline, Month 12, Month 24
Serum HDL-C concentration measured in millimoles per liter (mmol/L) using direct enzymatic assay after overnight fasting. Higher values indicate better cardiovascular risk profile. Reported as mean value at each assessment time point.
Concentration of Fasting Plasma Glucose
时间窗: Baseline, Month 12, Month 24
Fasting plasma glucose concentration measured in millimoles per liter (mmol/L) using hexokinase method after at least 8 hours of fasting. Reported as mean value and number of participants with values ≥7.0 mmol/L at each assessment time point.
Concentration of Glycated Hemoglobin (HbA1c)
时间窗: Baseline, Month 12, Month 24
HbA1c level measured as percentage (%) using high-performance liquid chromatography (HPLC) method standardized to National Glycohemoglobin Standardization Program (NGSP). Lower values indicate better glycemic control. Reported as mean value and number of participants with HbA1c ≥6.5% at each assessment time point.
次要结局
- Concentration of Serum Creatinine(Baseline, Month 12, Month 24)
- White Blood Cell Count(Baseline, Month 12, Month 24)
- Red Blood Cell Count(Baseline, Month 12, Month 24)
- Hemoglobin Concentration(Baseline, Month 12, Month 24)
- Platelet Count(Baseline, Month 12, Month 24)
- Urine Red Blood Cell Coun(Baseline, Month 12, Month 24)
- Urine White Blood Cell Count(Baseline, Month 12, Month 24)
- Urine Bacterial Count(Baseline, Month 12, Month 24)
- Concentration of Fasting Insulin(Baseline, Month 12, Month 24)
- Concentration of Serum C-Peptide(Baseline, Month 12, Month 24)
- Concentration of 25-Hydroxyvitamin D [25(OH)D](Baseline, Month 12, Month 24)
- Concentration of Interleukin-6 (IL-6)(Baseline, Month 12, Month 24)
- Concentration of Interleukin-10 (IL-10)(Baseline, Month 12, Month 24)
- Concentration of Interleukin-1β (IL-1β)(Baseline, Month 12, Month 24)
- Concentration of Tumor Necrosis Factor-alpha (TNF-α)(Baseline, Month 12, Month 24)
- Concentration of High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline, Month 12, Month 24)