To investigate the association between longitudinal trajectories of metabolic risk clusters and the risk of progression to end-stage kidney disease (ESKD) and major adverse kidney events (MAKEs) in patients with chronic kidney disease (CKD).
Prospective registry-based cohort study.
Secondary and tertiary care settings in Taiwan, using data from a multidisciplinary pre-ESKD care programme.
A total of 1494 adult patients with CKD stages 3b–5 enrolled in a structured pre-ESKD care programme.
Time to initiation of dialysis (primary outcome) and time to MAKE, defined as a composite of dialysis initiation or all-cause mortality (secondary outcome). Group-based multitrajectory modelling was used to categorise longitudinal trajectories of metabolic risk clusters, including systolic blood pressure, fasting blood glucose and low-density lipoprotein (LDL) cholesterol.
Four trajectory groups were identified: Group I had controlled blood pressure and glucose but elevated LDL (dialysis incidence: 19.5 per 1000 person-years); Group II had borderline-high blood pressure and elevated glucose (33.6 per 1000 person-years); Group III had controlled glucose and low LDL but borderline-high blood pressure (38.8 per 1000 person-years) and Group IV had controlled glucose but elevated blood pressure and LDL (46.7 per 1000 person-years). Compared with the other groups, Group I exhibited significantly longer dialysis-free and MAKE-free survival (log-rank test, p
Longitudinal trajectories of metabolic risk cluster are associated with differential risks of CKD progression to ESKD and death. Our findings provide valuable insights into the monitoring of metabolic risk profiles over time in patients with CKD.
To assess the incidence and risk of major adverse cardiovascular events (MACE) in patients with different stages of chronic kidney disease (CKD) and end-stage kidney disease (ESKD) in Taiwan.
Retrospective cohort study.
Secondary and tertiary care; data were collected from three affiliated hospitals in northern Taiwan.
A total of 7038 adult patients with clinically confirmed CKD stages 3–5 were included, of whom 14.09% had progressed to ESKD. Patients were identified from a multicentre database in northern Taiwan. Key exclusion criteria included age under 20 years, prior MACE, cancer or renal transplantation.
The primary outcome was the incidence of MACE during follow-up. Secondary analyses included time to MACE and subgroup comparisons by CKD stage and comorbid conditions (eg, diabetes, cardiovascular disease).
MACE occurred in 49.8% of patients with CKD and 64.1% of those with ESKD. After adjustment for covariates, the ESKD group had a significantly higher risk of MACE (HR=1.52; 95% CI 1.08 to 2.16) compared with the non-ESKD group. Relative to stage 3a, the adjusted HRs for MACE were 1.13 (95% CI 0.74 to 1.73) for stage 3b, 1.13 (95% CI 0.74 to 1.70) for stage 4, 1.82 (95% CI 1.18 to 2.81) for stage 5 (non-ESKD) and 2.32 (95% CI 1.51 to 3.57) for stage 5D (ESKD). Diabetes and cardiovascular comorbidities were associated with increased MACE incidence and shorter time to MACE, but their associations became non-significant after adjustment.
Based on a multicentre cohort from Taiwan, our findings provide insights into the prognosis of patients with CKD across disease stages and highlight the importance of targeted interventions and integrated care to improve cardiovascular outcomes.
To investigate, in a prospective cohort study, the association between cognitive impairment and cardiovascular disease (CVD), to quantify the extent to which uncontrolled risk factors mediate this association, and to explore whether the mediation effect varies across sex and age groups.
Prospective cohort study.
UK Biobank, a large population-based cohort study in the UK.
A total of 152 155 participants without prevalent CVD or dementia at baseline were included. The mean age was 56.3±8.2 years, and 44.0% were male.
Cardiovascular death and composite cardiovascular outcomes, assessed using Cox proportional-hazards models and mediation analyses.
During a median follow-up of 13.03–13.87 years, 1474 cardiovascular deaths and 21 518 composite cardiovascular outcomes were recorded. Participants with cognitive impairment (n=23 146; 15.2%) exhibited higher proportions of lifestyle, metabolic and psychological risks (p
Cognitive impairment is associated with increased risks of cardiovascular death and composite cardiovascular outcomes. Uncontrolled lifestyle, cardiometabolic and psychological risk factors partially mediate this association, highlighting the importance of comprehensive management to improve cardiovascular prognosis in this population.
High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.
The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.
Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.
Undergoing pancreatic surgery represents an exceptional situation for the individual patient who therefore requires appropriate preoperative information. In daily clinical practice, however, there is often a lack of time for adequate patient information and education, which may be associated with stress, fears and worries with potentially negative impact on patient-reported and postoperative outcomes. The aim of the INFORM trial is to evaluate the impact of video-assisted preoperative patient information on patient-reported and surgical outcomes in patients scheduled for elective pancreatic resection.
The INFORM trial is an open-label, randomised controlled pilot trial with two parallel study groups and a planned sample size of 80 patients with any indication for pancreatic resection. The intervention group will receive access to videos providing detailed information on the planned surgery and the perioperative procedures within 2 weeks before surgery in addition to the standard preoperative preparations. The control group will only receive the standard preoperative preparations without video. Quality of life (QLQ), satisfaction with information on disease and treatment as well as disease symptoms will be assessed using the European Organisation For Research and Treatment of Cancer QLQ INFO25, C30 and PAN26 questionnaires. Surgical complications will be assessed according to appropriate classifications by Clavien and Dindo and the International Study Group of Pancreatic Surgery (ISGPS). To account for the potential impact of cancer treatment on the outcome parameters, a subgroup analysis including only patients without malignancy will be performed. In addition, potential influencing factors on QLQ scores will be investigated by comparing QLQ scores among appropriate subsets of patients.
This trial was approved by the institution’s Ethics Committee (reference number 1479/2024). All trial procedures are performed in accordance with the ICH E6 harmonised tripartite guideline on Good Clinical Practice and the ethical principles of the Declaration of Helsinki. Once the study has been completed, the results will be published in due course.
German Clinical Trial Register number: DRKS00035173. Registered 14 October 2024 (https://drks.de/search/de/trial/DRKS00035173/details).
This systematic review aims to: (1) evaluate how behavioural and psychological factors have been incorporated into cardiovascular disease (CVD) risk prediction models; (2) assess their impact on model performance metrics such as area under the curve (AUC) and net reclassification index (NRI); and (3) identify which specific variables are most consistently associated with predictive improvements. This protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols (PRISMA-P) 2015, and the systematic review will follow the Cochrane Handbook and report findings based on PRISMA 2020.
A systematic review protocol developed in accordance with the (PRISMA-P) 2015 guidelines.
Systematic searches will be carried out in PubMed, Scopus, Web of Science and Google Scholar, limited to studies published from 2019 to 2024.
Peer-reviewed original studies involving adult populations (≥18 years) at risk of CVD, incorporating at least one behavioural or psychological variable into a CVD risk prediction model. Studies must report model performance metrics such as AUC or NRI. Studies focusing solely on biochemical or demographic factors, paediatric populations, or non-CVD outcomes will be excluded.
Two independent reviewers will screen eligible studies, extract data and assess study quality using the Newcastle-Ottawa Scale and Quality in Prognostic Studies tool. A narrative synthesis will be performed, with meta-analysis conducted if feasible.
Ethical approval is not required for this study. Findings will be disseminated through peer-reviewed publication and conference presentations.
CRD420251014218.
Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.
This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.
This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.