Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 6
- 主要终点
- number of death
研究概览
简要总结
Epidemiological studies are usually conducted in the general population in adults without complications or pathology at baseline. The results obtained are therefore often better designed for primary prevention use. The prediction of mortality risk in patients with complications and requiring hospital follow-up is less well known.
The study purpose is to determine a mortality risk profile in a hospital cohort of patients with pathologies associated with metabolic diseases.
Today the "multimaker" scores based on a panel of biomarkers - have significantly improved the discriminating power of prediction models existing in many pathologies. It is no longer a single biomarker that can improve risk prediction but a complete and cross-sectional profile that is sought after. We aim to establish a personalised mortality risk profile by combining clinical and biological parameters including metabolomics, genetics, transcriptomics and epigenomics by high throughput screening of biological samples.
详细描述
The prediction of the onset of diabetes and metabolic complications, especially cardiovascular, renal, or hepatic, is a major challenge to optimize the management of this disease.
Teams from the University Hospital of Lille have developed the Integra cohort study to identify the clinical and biological determinants of the occurrence of these complications and the mortality of patients with metabolic disorders.
The aim of the study is to identify clinico-biological determinants that are able to predict the occurence of death, cardiovascular events as well as hepatic or nephrotic one.
Follow-up data will be collected from National System of Health Data (SNDS) where data concerning hospitalisations, medical consultations and treatments are registered.
Biological samples are collected at baseline for a large OMICs analysis (metabolomics, genetics, transcriptomics and epigenomics) that would feed our predictive scoring system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic: antecedent - treatment - or glycemia> = 1.26 g / dl - or HbA1C> = 6.5% and or
- •Obese: BMI> = 30 and or
- •Metabolic syndrome defined AND
- •Patient having given written consent to participate in the study or collection of the consent of the witness
- •Social insured patient (excluding AME)
- •Patient willing to comply with all procedures of the study and its duration AND
- •Patient also presenting a pathology among:
- •Cardiology:
- •Coronary patient(history of myocardial infarction, coronary bypass, or coronary angioplasty or stenosis greater than 50% on an epicardial vessel documented on coronary angiography)
- •Patient with systolic or diastolic heart failure
- •Patient with atrial fibrillation
- •Patient with aortic stenosis (Vmax> 2.5 m / s)
- •Patient with high blood pressure
- •neurology:
- •ischemic stroke
- •intracerebral hemorrhage
- •transient ischemic attack
- •diabetology:
- •Obesity without diabetes
- •Diabetes T2
- •T1 diabetes
- •Monogenic Diabetes / MODY
- •African Diabetes
- •Diabetes secondary to pancreatopathy / liver cirrhosis
- •Diabetes post transplantation / post immunotherapy
- •Diabetes associated with Steinert's disease
- •hepatology: hepatological pathology
- •nephrology: nephrology
排除标准
- •Unscheduled hospitalization less than 3 months old
- •Ongoing treatment :
- •Cytotoxic chemotherapy
- •Radiotherapy
- •HIV and / or HCV and / or active HBV infection
- •OMS score> = 2
- •Pregnant woman
结局指标
主要结局
number of death
时间窗: at 10 years
The number of patients dead according to national database
次要结局
- Occurrence of macrovascular complications (composite criteria)(at 10 years)
- hospitalization for heart failure(at 10 years)
- Occurence of renal microvasculare complications (composite criteria)(at 10 years)
- Occurrence of liver complications(composite endpoint)(at 10 years)
- Occurrence of hemorrhages measured by BARC >3 bleeding(at 10 years)