REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study) (RECREATE Pilot)
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
研究概览
详细说明
Patients will be randomly assigned to either the control arm and will receive usual AMI care or the experimental arm, which will include routine AMI care as well as intensive therapy intervention.
In addition to the capillary blood glucose measurements obtained to titrate insulin doses in the experimental arm patients, laboratory plasma glucose will be drawn in all patients at randomization, 10, 24, 48, and 72 hours post randomization, 7 days post randomization (or hospital discharge if that occurs first), and 30 days post randomization.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Ontario
-
Hamilton、Ontario、加拿大、L8L 2X2
- Hamilton Health Sciences, General Site
-
-
-
-
-
Nagpur、印度、440012
- Avanti Institute of Cardiology
-
-
Assam
-
Dt. Dibrugarh、Assam、印度、786002
- Assam Medical College Hospital
-
-
Chattisgarh
-
Raipur、Chattisgarh、印度、492001
- Lifeworth Super Specialty Hospital
-
-
Haryana
-
Rohtak、Haryana、印度、124001
- Post Graduate Institute of Medical
-
-
Karnataka
-
Bangalore、Karnataka、印度、560034
- St. Johns Medical College
-
Shimoga、Karnataka、印度、577201
- Nanjappa Hospital
-
-
Kerala
-
Calicut、Kerala、印度、673004
- Baby Memorial Hospital
-
Kottayam、Kerala、印度、686016
- Caritas Hospital
-
-
Maharashtra
-
Mumbai、Maharashtra、印度、400012
- KEM Hospital
-
Wardha、Maharashtra、印度、442102
- MGIMS
-
-
Tamilnadu
-
Chennai、Tamilnadu、印度、600023
- Railway Hospital
-
-
-
-
Buenos Aires
-
Adrogue,、Buenos Aires、阿根廷
- Instituto Médico Adrogué
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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)
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Control
Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre.
|
|
实验性的:Intervention
The experimental arm will have an IV infusion of glulisine insulin started directly after randomization for at least 24 hours and for as long as CCU-level care is required, and the insulin infusion will be adjusted to achieve and maintain a target glucose range of 5.0-6.6 mmol/L (90-118 mg/dL).
Once transferred to the ward, patients in the experimental arm will switch to glargine insulin and will continue this treatment for the remainder of their hospitalization and after hospital discharge, for a total duration of 30 days post randomization.
|
IV infusion of glulisine, SC injection of glargine
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The 24-hour difference in mean glucose between the two study groups.
大体时间:24 hours
|
24 hours
|
次要结果测量
结果测量 |
大体时间 |
---|---|
The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
大体时间:7 days or discharge
|
7 days or discharge
|
The difference in mean glucose level achieved at 30 days between study groups
大体时间:30 days
|
30 days
|
Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes)
大体时间:Discharge, 30 days, 90 days, 1 year
|
Discharge, 30 days, 90 days, 1 year
|
Rehospitalization for congestive heart failure
大体时间:Discharge, 30 days, 90 days, 1 year
|
Discharge, 30 days, 90 days, 1 year
|
All cause mortality
大体时间:Discharge, 30 days, 90 days, 1 year
|
Discharge, 30 days, 90 days, 1 year
|
Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
大体时间:Discharge, 30 days, 90 days, 1 year
|
Discharge, 30 days, 90 days, 1 year
|
Cardiogenic shock
大体时间:Discharge, 30 days, 90 days, 1 year
|
Discharge, 30 days, 90 days, 1 year
|
Cardiac procedures
大体时间:Discharge, 30 days, 90 days, 1 year
|
Discharge, 30 days, 90 days, 1 year
|
Rehospitalization for any cause
大体时间:Discharge, 30 days, 90 days, 1 year
|
Discharge, 30 days, 90 days, 1 year
|
Symptomatic and severe hypoglycemic episodes
大体时间:Discharge, 30 days, 90 days, 1 year
|
Discharge, 30 days, 90 days, 1 year
|
Hypokalemic episodes
大体时间:Discharge
|
Discharge
|
合作者和调查者
调查人员
- 首席研究员:Hertzel Gerstein, MD, MSc, FRCPC、McMaster University
- 首席研究员:Salim Yusuf, DPhil, FRCPC, FRSC、McMaster University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
glulisine insulin, glargine insulin的临床试验
-
Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbH完全的
-
Mannkind Corporation完全的
-
Julphar Gulf Pharmaceutical IndustriesProfil Institut für Stoffwechselforschung GmbH完全的