Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Differences in daily blood glucose mean concentration between treatment groups
研究概览
简要总结
The study aims to demonstrate that a simple intravenous insulin algorithm can be implemented in Latin America and will result in safe and better glucose control in patients with Acute Coronary Syndrome (ACS) compared with SC insulin.
详细描述
The proposed study is a one center open-label randomized controlled clinical trial.Coronary Intensive Care of one hospital in the city of Curitiba, PR, Brazil will be assessed.
Consenting eligible subjects will be randomized to either the intensive insulin infusion therapy group (ITG) or the conventional therapy group (CTG).
This particular insulin infusion was adapted of a protocol has been used before in patients who underwent to cardiothoracic surgery and its efficacy has been reported in the literature.
The control group will be selected following the same set of inclusion and exclusion criteria. Patients will be randomized to receive SC regular insulin 4 times daily (before meals and bedtime) or every 6 hours if they are NPO .
Data will be collected for history of diabetes, heart disease ; hypertension; hyperlipidemia; Current smoker; Cardiac treatment (Aspirin, Beta Blockers, ACE inhibitor/A2RB, Nitrates, Statin, Fibrate) Diabetes treatment(Insulin, Metformin, Sulphonylureas) Data will be collect for Baseline BGL , A1C level, Troponin, CPK, CKP-Mb, K, Creatinine. Classify Infarct type : Anterior/anteroseptal, Inferior, Non-ST-segment elevation myocardial infarction, Not classified Cardiac intervention : PTCA , Thrombolysis,No reperfusion, Heparin or low-molecular weight heparin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 18 or older
- •Evidence of AMI within the last 24 h (troponin-T >0.1mcg/l) or electrographic criteria of ST-segment elevation in two limb leads)
- •Evidence of Unstable Angina
- •Blood glucose >180mg/dL at admission with or without preexisting diabetes
- •Willing to give informed consent
- •Access to telephone communications after hospital discharge
排除标准
- •Under 18 years of age
- •Pregnant or lactating female
- •Diabetes ketoacidosis
- •Heart failure
- •Cardiogenic shock
研究组 & 干预措施
Insulin
Intensive Insulin Therapy
干预措施: Regular Insulin (Drug)
Regular Insulin
Sub Cutaneous Regular Insulin
干预措施: Regular Insulin (Drug)
结局指标
主要结局
Differences in daily blood glucose mean concentration between treatment groups
时间窗: 18 months
次要结局
- Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC)(18 month)
研究者
Silmara A O Leite
PhD
Universidade Positivo
