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临床试验/NCT03059550
NCT03059550Unknown不适用

Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation After an Acute Coronary Syndrome (REHABDIAB [REHABilitation for Coronary Disease and DIABetes])

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
试验地点
1
主要终点
Percentage of OGTT performed after an acute coronary syndrome

研究概览

简要总结

Because prevalence of glucose metabolism disorders is high in patients with coronary disease, the Oral Glucose Tolerance Test (OGTT) is recommended in all patients without diabetes after an acute coronary syndrome (ACS). However, there are some concerns about its performance in clinical practice. The aim of our study was to evaluate, after an acute coronary syndrome (ACS), the feasibility and efficacy of the OGTT in a cardiac rehabilitation (CR) center in comparison with its real application in the whole French population.

详细描述

We will select all the patients referred to our Cardiac Rehabilitation center after an ACS. HbA1c will be measured in each patient included in the study. the OGTT will be prescribed in all the patients without known diabetes and with HbA1c < 6.5%. In order to perform a "real life" study, the OGTT will not performed in the CR center but will prescribed in each patient who will be asked to perform it in an external biological laboratory.

The OGTT will be performed in the morning after a 12 hour fast, with 75g oral glucose load. Plasma glucose will be measured at baseline and 120 min after the oral glucose load. The results will be classified according to the WHO criteria: diabetes is defined as fasting plasma glucose (FPG) greater or equal to 7.0 mmol/L (126 mg/dL) or glucose level 2h (2hPG) after the OGTT greater or equal to 11.1mmol/L (200mg/dL); impaired fasting glucose (IFG) is defined as FPG greater or equal to 6.1 mmol/L (110mg/dL) and less than 7.0 mmol/L and impaired glucose tolerance (IGT) is defined as a 2hPG greater or equal to 7.8 mmol/L (140 mg/dL) and less than 11.1mmol/L.

In parallel, screening for glucose metabolism disorders with the OGTT after an ACS will be evaluated in the whole French population from a representative sample of 1/97ème French population of the "National Health Insurance Inter-Regime Information System" (SNIIRAM) which collects individual hospital and non-hospital data for health care consumption.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • patients referred to cardiac rehabilitation after an acute coronary syndrome during the 6 precious weeks

排除标准

  • 未提供

结局指标

主要结局

Percentage of OGTT performed after an acute coronary syndrome

时间窗: 26 months

Percentage of OGTT performed after an acute coronary syndrome

次要结局

  • Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation(26 months)
  • Profile of the patients according to their glucose abnormalities(26 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Bruno Vergès

Professor

Centre Hospitalier Universitaire Dijon

研究点 (1)

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