Performance of NT-proBNP in Risk Stratification for Cardiovascular Events and Mortality in Patients With Diabetes (PISCES)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Number of participants with composite endpoint based on first occurrence of all-cause death or cardiovascular events
研究概览
简要总结
More than 400 million people have type 2 diabetes (T2D) globally, and the burden of diabetes-related cardiovascular complications is increasing. Cardiovascular disease (CVD) affects approximately one-third of all individuals with T2D and accounts for half of all deaths in this population despite major advances in the treatment of the disease. Among the different types of CVD, heart failure (HF) is frequently the first CVD manifestation in individuals with T2D. Although the link between T2D and CVD is widely recognised, the absolute risk of cardiovascular events varies among individuals with T2D. As such, effective risk-stratification tool that accurately identify T2D patients at the highest risk of developing incident or recurrent cardiovascular (CV) events is needed.
B-type natriuretic peptide (BNP) and its inactive N-terminal precursor NT-proBNP are biomarkers of myocardial stress. They been shown to incrementally improve predictive discrimination of death and CV events in high-risk individuals with T2D.
An NT-proBNP-based CVD/HF risk stratification strategy has not been prospectively tested in the multi-ethnic T2D population in Singapore. In this study, we aim to:
- Evaluate the predictive value of NT-proBNP for death and CV events compared to traditional risk markers [e.g. HbA1c, albuminuria, high sensitivity C-reactive protein (hsCRP), high sensitivity troponin-T (hsTnT)] in a cohort of T2D patients with or without established CVD (defined as ischaemic heart disease, myocardial infarct, unstable angina, prior coronary artery revascularisation, stroke, transient ischaemic attack or PAD) attending a tertiary diabetes care centre. (Patients with history of HF will be excluded.)
- Compare the performance of NT-proBNP as a single biomarker for CV risk prediction to risk scoring algorithms in T2D patients.
详细描述
This is a prospective single-site, observational study to evaluate the predictive value of NT-proBNP for death and CV events compared to traditional CV risk markers (e.g., HbA1c, albuminuria, hsCRP and hsTnT) in T2D patients with or without established CVD (defined as ischaemic heart disease, myocardial infarct, unstable angina, prior coronary artery revascularisation, stroke, transient ischaemic attack or PAD). Patients with history of HF will be excluded. The study will also compare the performance of NT-proBNP as a single biomarker for CV risk prediction to other risk scoring algorithms such as UK Prospective Diabetes Study (UKPDS) risk engine, Risk Equations for Complications Of Type 2 Diabetes (RECODe) and University of Hong Kong-Singapore (HKU-SG) risk scores.
The study will prospectively recruit 1200 adults (aged 40 and above) with T2D from Singapore General Hospital (SGH) over a period of 18 months. Informed consent will be obtained from patients before the start of any procedures. There will be 1 baseline visit to collect demographic information, and clinical and laboratory data. Baseline point-of-care echocardiography will also be performed for all patients. All patients will subsequently be observed over 5 years for the occurrence of death or CV events through monitoring of electronic health records (EHR) and telephone contacts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (T2D) of at least 6 months' duration
- •Age 40 and older
排除标准
- •Known history of heart failure (self-reported and medical records review)
- •Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2 [using the CKD-Epidemiology Collaboration (CKD-EPI) 2021 equation for glomerular filtration rate] based on the last known eGFR within 12 months of study recruitment)
- •Renal replacement therapy
- •Systemic treatment with corticosteroids or immunosuppressants
- •Pregnant or nursing women
- •Active cancer disease
- •Serious disease with life expectancy <1 year as judged by the doctor
- •Any condition that, in the investigator's opinion, would interfere with a subject's ability to comply with study protocol or procedures
结局指标
主要结局
Number of participants with composite endpoint based on first occurrence of all-cause death or cardiovascular events
时间窗: 5 years
Composite endpoint based on the first occurrence of all-cause death or CV events consisting of a composite of non-fatal myocardial infarction, non-fatal stroke, unplanned hospitalisation for heart failure (HHF), coronary revascularisation (PCI or CABG), non-traumatic lower limb amputation, or lower limb arterial revascularisation (surgical or endovascular).
次要结局
- Number of participants with all-cause death(5 years)
- Number of unplanned hospitalization for heart failure (HHF)(5 years)
- Number of participants with 4-point major adverse cardiovascular event (MACE)(5 years)
- Number of participants with cardiovascular (CV) death(5 years)
- Number of participants with all-cause hospitalization(5 years)