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临床试验/NCT01151176
NCT01151176暂停4 期

Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome

Universidade Positivo2 个研究点 分布在 2 个国家目标入组 130 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Intensive Insulin Therapy

干预措施: Regular Insulin (Drug)

Regular Insulin

Other

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

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

Silmara A O Leite

PhD

Universidade Positivo

研究点 (2)

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