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临床试验/NCT02250989
NCT02250989Unknown不适用

Influence of Glycaemia and Insulinemia on Vasomotor Endothelial Function After Ischemia/Reperfusion Lesion on Patients in Acute Phase of ST Segment Elevation Myocardial Infarction (STEMI)

University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
1
主要终点
Change in endothelial function after ischemia/reperfusion injury

研究概览

简要总结

The objective of this study is to investigative the influence of different levels of glycaemia or insulinemia in vascular endothelium in ischemia/reperfusion lesion after myocardial infarction

详细描述

The study will include patients consecutively admitted with acute myocardial infarction at State University of Campinas Hospital. Participants will be evaluated during hospitalization and, after they fulfill the inclusion criteria and sign an informed consent, it will be collected a brief medical history and recorded results from glycated hemoglobin (HbA1c), glycaemia, total cholesterol (TC), triglycerides (TG), HDL cholesterol (HDL-C), C-reactive protein (CRP), urea (U), creatinine (Cr), markers of myocardial necrosis (troponin T and CK-MB), Hemoglobin, Red blood cell, Leucocytes, Na, K, Ca and Mg.

In the first week after infarction, from admission until the realization of the clamps experiments (the medical procedure where blood glucose and insulin levels will be controlled), all medications prescribed, medical history and examination will be recorded, as well as follow-up during hospitalization.

At the day of the clamp, between 144 and 168 hours after infarction, volunteers will be randomized to one of the three situations with different glycemic and insulinemic conditions, i.e., a) high insulinemia and low glycaemia, b) high insulinemia and high glycaemia and c) low insulinemia and high glycaemia. During these experiments, endothelial vasomotor function will be recorded in four periods: i) before initiation of the procedure, ii) after 1h of the beginning, iii) 30 minutes after the second procedure and iv) 15 minutes after the simulation of ischemia/reperfusion lesion. In each time point, the investigators will collect plasma to dose inflammatory, oxidative stress and vascular activation markers.

Hospital care of subjects

The patients included in this survey will be treated according to actual guidelines. Briefly, will be enrolled patients who underwent primary angioplasty within 6 hours after symptoms onset, were introduced antiplatelet and anticoagulation therapy at the correct dose, respectively Acetylsalicylic Acid (ASA) 200 mg and Clopidogrel 300 mg, and enoxaparin 30 mg. In patients without contraindication, it will be administered in the first 24 hours beta-blockers and ACEi in those with ejection fraction (EF) <0.4, previous MI or prior heart failure. Upon admission, if there is no contraindication, simvastatin 40 mg/day will be administered. As a maintenance dose, the investigators will administer ASA 100 mg, clopidogrel 75 mg, enoxaparin 1 mg/kg twice daily, simvastatin 40 mg, propranolol 40 mg or metoprolol 50 mg (beta-blockers available at the hospital) and captopril 25 mg (most used ACEi). Patients will be treated preferably in the Coronary Unit (CU). Researchers may suggest the physician responsible for the patient care to prescribe the above medications, as well as question why the drugs listed in the guidelines are not being used. The reasons and specific contraindications will be recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • less than 12 hours from the onset of symptoms of STEMI,
  • reperfusion therapy performed less than 6 hours of symptom onset.

排除标准

  • patients that after 24 hours did not show markers of myocardial necrosis
  • diabetes or use of oral antidiabetics
  • admission with glycosylated hemoglobin ≥ 6.5%
  • patients with creatinine clearance <50 ml / min,
  • patients with BMI ≥ 40 kg / m2,
  • premenopausal women,
  • patients that used nitrate or vasoactive drugs (norepinephrine, dobutamine, nitroglycerin or nitroprussiate in 48h prior to the examination of endothelial function
  • cardiac dysfunction in acute MI with or without repercussion clinic, diagnosed by ejection fraction less than 50% left ventricle.
  • FMD values above or below 2 standard deviations or more from the average of these tests

结局指标

主要结局

Change in endothelial function after ischemia/reperfusion injury

时间窗: Between 144 and 168 h after Myocardial Infarction

Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on endothelial reactivity, measured by flow mediated dilation, after ischemia/reperfusion injury assessed at brachial artery.

次要结局

  • Change in inflammatory markers after ischemia/reperfusion injury(Between 144 and 168 h after Myocardial Infarction)
  • Change in biomarkers of endothelial dysfunction before and after ischemia/reperfusion injury(Between 144 and 168 h after MI)
  • Change in plasma pool of nitric oxide after ischemia/reperfusion injury(Between 144 and 168 h after Myocardial Infarction)
  • Change in biomarkers of oxidative stress before and after ischemia/reperfusion injury(Between 144 and 168h after MI)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrei Carvalho Sposito

Assistent Professor, Cardiology Division

University of Campinas, Brazil

研究点 (1)

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