Cardiovascular-Kidney-Metabolic Syndrome
Conditions
Keywords
Comprehensive Health Management Platform, Mobile Health, Early identification, Cardiovascular-Kidney-Metabolic Syndrome
Brief summary
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.
Detailed description
1.Construction of a Comprehensive CKM Health-Management Platform 1. 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. 2. Data integration & governance: Health data from electronic health records, laboratory reports and wearables will be unified. Privacy, security and regulatory compliance will be ensured. 3. 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.
Interventions
BEHAVIORALComprehensive Health Management Platform
The health-management programme comprises: * Screening: collection of demographic data, medical and personal history, physical examination (blood pressure, heart rate, etc.), laboratory tests (inflammatory markers, lipids, glucose, renal and liver function), exercise habits, nutritional status, body-composition analysis, and physical-fitness tests (reaction time, grip strength, vertical jump, one-leg stance with eyes closed, back strength, sit-and-reach, 1-min sit-ups, 1-min push-ups, cardiopulmonary exercise test). * Assessment: CKM risk stratification based on the above. ③ Intervention: individualised exercise, dietary and pharmacological prescriptions. * Follow-up: ongoing monitoring of clinical indices, exercise, diet and medication adherence by a physician-health-manager team.
OTHERPost-examination follow-up management
Post-examination report interpretation service and telephone follow-up for patients with abnormal findings.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* CKM stage 3-4 * Acute or critically ill conditions requiring hospitalization * Malignant tumors or any active cancer under treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Height | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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) | 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 | 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 | 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) | 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) | 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| White Blood Cell Count | Baseline, Month 12, Month 24 | White blood cell count measured in 10\^9 cells per liter (10\^9/L) using automated hematology analyzer. Reported as mean value at each assessment time point. |
| Red Blood Cell Count | Baseline, Month 12, Month 24 | Red blood cell count measured in 10\^12 cells per liter (10\^12/L) using automated hematology analyzer. Reported as mean value at each assessment time point. |
| Hemoglobin Concentration | Baseline, Month 12, Month 24 | Hemoglobin concentration measured in grams per liter (g/L) using cyanmethemoglobin method. Reported as mean value and number of participants with values below lower limit of normal (LLN) at each assessment time point. |
| Platelet Count | Baseline, Month 12, Month 24 | Platelet count measured in 10\^9 cells per liter (10\^9/L) using automated hematology analyzer. Reported as mean value at each assessment time point. |
| Urine Red Blood Cell Coun | Baseline, Month 12, Month 24 | Red blood cell count in urine measured in cells per high-power field (cells/HPF) using microscopic examination of centrifuged urine sediment. Reported as mean value and number of participants with values above 3 cells/HPF at each assessment time point. |
| Urine White Blood Cell Count | Baseline, Month 12, Month 24 | White blood cell count in urine measured in cells per high-power field (cells/HPF) using microscopic examination of centrifuged urine sediment. Reported as mean value and number of participants with values above 5 cells/HPF at each assessment time point. |
| Urine Bacterial Count | Baseline, Month 12, Month 24 | Bacterial count in urine measured in colony-forming units per milliliter (CFU/mL) using quantitative urine culture. Reported as number and percentage of participants with bacterial count ≥10\^5 CFU/mL at each assessment time point. |
| Concentration of Serum Creatinine | Baseline, Month 12, Month 24 | Serum creatinine concentration measured in micromoles per liter (μmol/L) using enzymatic method. Reported as mean value at each assessment time point. |
| Concentration of Fasting Insulin | Baseline, Month 12, Month 24 | Serum fasting insulin concentration measured in picomoles per liter (pmol/L) or microunits per milliliter (μIU/mL) using chemiluminescent immunoassay after at least 8 hours of fasting. Reported as mean value and calculated Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index at each assessment time point. |
| Concentration of Serum C-Peptide | Baseline, Month 12, Month 24 | Serum C-peptide concentration measured in nanomoles per liter (nmol/L) or nanograms per milliliter (ng/mL) using chemiluminescent immunoassay after at least 8 hours of fasting. Reported as mean value at each assessment time point. |
| Concentration of 25-Hydroxyvitamin D [25(OH)D] | Baseline, Month 12, Month 24 | Serum 25-hydroxyvitamin D concentration measured in nanomoles per liter (nmol/L) or nanograms per milliliter (ng/mL) using chemiluminescent immunoassay (CLIA) or liquid chromatography-tandem mass spectrometry (LC-MS/MS). 25(OH)D is the major circulating form of vitamin D and reflects vitamin D status. Higher values indicate better vitamin D sufficiency. Reported as mean value and number of participants with 25(OH)D \<50 nmol/L (20 ng/mL) indicating deficiency, 50-75 nmol/L (20-30 ng/mL) indicating insufficiency, and ≥75 nmol/L (30 ng/mL) indicating sufficiency at each assessment time point. |
| Concentration of Interleukin-6 (IL-6) | Baseline, Month 12, Month 24 | Serum interleukin-6 concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. IL-6 is a pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point. |
| Concentration of Interleukin-10 (IL-10) | Baseline, Month 12, Month 24 | Serum interleukin-10 concentration measured in picograms per milliliter (pg/mL) using enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. IL-10 is an anti-inflammatory cytokine. Higher values may indicate compensatory anti-inflammatory response. Reported as mean value at each assessment time point. |
| Concentration of Interleukin-1β (IL-1β) | Baseline, Month 12, Month 24 | Serum interleukin-1β concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA). IL-1β is a key pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value at each assessment time point. |
| Concentration of Tumor Necrosis Factor-alpha (TNF-α) | Baseline, Month 12, Month 24 | Serum tumor necrosis factor-alpha concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. TNF-α is a major pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value at each assessment time point. |
| Concentration of High-Sensitivity C-Reactive Protein (hs-CRP) | Baseline, Month 12, Month 24 | Serum high-sensitivity C-reactive protein concentration measured in milligrams per liter (mg/L) using immunoturbidimetric assay or nephelometry. hs-CRP is an acute-phase reactant and marker of systemic inflammation. Lower values indicate lower cardiovascular risk and systemic inflammation. Reported as mean value and number of participants with hs-CRP \<1 mg/L (low risk), 1-3 mg/L (moderate risk), and \>3 mg/L (high risk) for cardiovascular disease at each assessment time point. |
Outcome results
None listed