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临床试验/NCT00209144
NCT00209144已完成1 期

Effects of Intense Glycemic Control on Markers of Inflammation and Thrombosis in Patients Treated With Percutaneous Coronary Intervention for Acute Myocardial Infarction.

Emory University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2004年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
58
试验地点
2
主要终点
Troponin levels

研究概览

简要总结

The purpose of this study is to determine if intense control of high glucose levels in patients treated with angioplasty for heart attack has anti-inflammatory and anti-thrombotic effects.

详细描述

Two out of three heart attack patients have high blood sugar. Half of these patients have diabetes and the other half have what is called pre-diabetes, meaning that they have higher blood sugar than normal but not high enough to have diabetes. Over 40 million Americans have pre-diabetes.

For more than 70 years, doctors have known that patients with high blood sugar do not survive or recover from heart attacks as well as patients with normal blood sugar. Doctors have not figured out the reason for this difference.

The best treatment available for heart attacks is called angioplasty. Angioplasty means that doctors put a small balloon into a blocked blood vessel, blow up the balloon to open the blockage, and then insert a small wire tube called a stent to hold the blockage open. Blood thinners and other heart medicines are also given to these patients to help blood get through the blocked blood vessel. Angioplasty and these medicines have helped many people survive and recover from heart attacks. But even when doctors use these drugs, balloons and stents, patients who have high blood sugar still do worse than patients with normal blood sugar.

We want to figure out why high blood sugar is bad for patients with heart attacks. Past research tells us there might be two reasons. The first is that high blood sugar increases inflammation which is part of the body's natural response to heart attack. Inflammation is what causes a person's skin to turn hot and red after it is injured. Although inflammation is part of the body's natural healing process, too much inflammation can be harmful. We think that patients with high blood sugar during heart attacks have too much inflammation. The second reason why high blood sugar might be bad for heart attack patients is that high blood sugar makes blood thicker. When a blood vessel is blocked, thick blood makes it harder for the heart to get the blood flow it needs. This is why doctors use aspirin and other blood thinners when they treat patients with heart attacks.

The amount of inflammation and thickness in a person's blood can be measured in a laboratory. In this study, we want to measure the amount of inflammation and thickness in patients' blood to see if there is a difference between patients with normal blood sugar, patients with pre-diabetes, and patients with diabetes. If we can show that there is a difference, this will help us to understand why high blood sugar is bad for patients with heart attacks.

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 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients to be treated with percutaneous coronary intervention for myocardial infarction.

排除标准

  • MI > 6 hrs duration Thrombolytic therapy (within last 2 days) Recent inflammatory/infectious illness (last 2 weeks) Pregnancy Renal insufficiency (Cr > 2.0) Type I Diabetes Mellitus Initial BG >110 but <140 Enrollment in another research study

研究组 & 干预措施

Angioplasty with Insulin

Experimental

Coming in with acute infarct and received angioplasty with intensive insulin therapy

干预措施: Intensive insulin therapy (Drug)

结局指标

主要结局

Troponin levels

时间窗: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)

次要结局

  • CRP level(Baseline, 24 hours, 48 hours, and 72 hours (post-procedure))
  • B-type natriuretic peptide levels.(Baseline, 24 hours, 48 hours, and 72 hours (post-procedure))

研究者

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

Douglas Morris

Professor

Emory University

研究点 (2)

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