REsearching Coronary REduction by Appropriately Targeting Euglycemia ( Pilot Study):An International Multicentre Randomized Controlled Trial of Intensive Insulin Therapy Targeting Normoglycemia In Acute Myocardial Infarction: the RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia) Pilot Study
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 17
- 主要终点
- The 24-hour difference in mean glucose between the two study groups
研究概览
简要总结
This pilot study will be a multicentre, randomized, open-label, controlled trial. The trial will be conducted in Canada, Argentina and India.At least 500 patients presenting with AMI with ST-segment elevation or new left bundle branch block (LBBB), and a capillary blood glucose level on presentation ≥ 8.0 mmol/L (144 mg/dL), will be randomized in a 1:1 fashion via a 24-hour central system to receive either intensive insulin therapy with the goal of achieving and maintaining normoglycemia (intervention arm) or routineAMI care (control arm) (Figure 1). India will recruit about 250 patients from 10 - 15 centres. The recruitment in India is expected to start in February 2009 and the last date of enrollment is 30th November 2009. A cutoff of 8 mmol/l (144 mg/dL) has been selected because the subgroup of patients in CREATE-ECLA with a baseline glucose ≥ 8.0 mmol/L had a higher mortality rate at 30 days (12.7%) compared with patients with presenting glucose < 8.0 mmol/L (who had a 30-day mortality rate of 7.3%), and because insulin therapy is likely to be more efficacious in patients who present with higher glucose level
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Both nondiabetic patients and patients with non-insulin-requiring type 2 diabetes mellitus admitted with a suspected AMI are eligible if they meet the following criteria:Signs or symptoms of AMI with definite ECG changes, defined as persistent ST-segment elevation (> or = than 1 mm)in two or more contiguous leads, or new left bundle branch block Onset of symptoms within 24 hours before hospital presentation Capillary blood glucose level on presentation > or = 8.0 mmol/L (144 mg/dL).
排除标准
- •Exclusion Criteria:Patient with conditions that REQUIRE the administration of insulin, including:Type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30 Type 2 diabetes mellitus that was treated with insulin prior to AMI presentation Type 2 diabetes mellitus that is known to be very poorly controlled (e.g. admission capillary blood glucose > 16.0 mmol/L (288 mg/dL)or marked elevation in glucose for which the site investigator plans to treat with insulin therapy) A history of severe hypoglycemic episodes (defined as hypoglycemia with symptoms which the patient is unable to reverse without the assistance of another person) within the past two years Known or suspected end-stage liver disease (due to the risk of hypoglycemia in the setting of liver dysfunction and consequent impaired regulation of glucose homeostasis) Cardiogenic shock on admission (due to the inaccuracy of glucose meter readings) Documented pregnancy Any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days Anticipated poor adherence with study treatments or an other factor that might jeopardize 90-day follow-up (e.g. no fixed address, long distance to hospital, etc.) Prior enrollment in this trial or current enrollment in another trial of ST-segment elevation myocardial infarction.
结局指标
主要结局
The 24-hour difference in mean glucose between the two study groups
时间窗: 24 hours
次要结局
- the difference in mean glucose level achieved between study groups;(7 days or hospital discharge (whichever is first))
- b) the difference in mean glucose level between study groups;(achieved at 30 days)
- c) nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as acomposite and as separate outcomes);(30 days)
- d) rehospitalization for congestive heart failure;(30 days)
- e) all cause mortality;(30 days)
- f) resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes);(30days)
- g) cardiogenic shock;(30days)
- h) cardiac procedures;(30 days)
- i) rehospitalization for any cause.(30days)