<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02250989</url>
  </required_header>
  <id_info>
    <org_study_id>Ateroloab-1</org_study_id>
    <nct_id>NCT02250989</nct_id>
  </id_info>
  <brief_title>The Influence of Glycaemia and Insulinemia on Vasomotor Endothelial Function After Myocardial Infarction</brief_title>
  <acronym>INGLIVEF</acronym>
  <official_title>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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campinas, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigative the influence of different levels of&#xD;
      glycaemia or insulinemia in vascular endothelium in ischemia/reperfusion lesion after&#xD;
      myocardial infarction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include patients consecutively admitted with acute myocardial infarction at&#xD;
      State University of Campinas Hospital. Participants will be evaluated during hospitalization&#xD;
      and, after they fulfill the inclusion criteria and sign an informed consent, it will be&#xD;
      collected a brief medical history and recorded results from glycated hemoglobin (HbA1c),&#xD;
      glycaemia, total cholesterol (TC), triglycerides (TG), HDL cholesterol (HDL-C), C-reactive&#xD;
      protein (CRP), urea (U), creatinine (Cr), markers of myocardial necrosis (troponin T and&#xD;
      CK-MB), Hemoglobin, Red blood cell, Leucocytes, Na, K, Ca and Mg.&#xD;
&#xD;
      In the first week after infarction, from admission until the realization of the clamps&#xD;
      experiments (the medical procedure where blood glucose and insulin levels will be&#xD;
      controlled), all medications prescribed, medical history and examination will be recorded, as&#xD;
      well as follow-up during hospitalization.&#xD;
&#xD;
      At the day of the clamp, between 144 and 168 hours after infarction, volunteers will be&#xD;
      randomized to one of the three situations with different glycemic and insulinemic conditions,&#xD;
      i.e., a) high insulinemia and low glycaemia, b) high insulinemia and high glycaemia and c)&#xD;
      low insulinemia and high glycaemia. During these experiments, endothelial vasomotor function&#xD;
      will be recorded in four periods: i) before initiation of the procedure, ii) after 1h of the&#xD;
      beginning, iii) 30 minutes after the second procedure and iv) 15 minutes after the simulation&#xD;
      of ischemia/reperfusion lesion. In each time point, the investigators will collect plasma to&#xD;
      dose inflammatory, oxidative stress and vascular activation markers.&#xD;
&#xD;
      Hospital care of subjects&#xD;
&#xD;
      The patients included in this survey will be treated according to actual guidelines. Briefly,&#xD;
      will be enrolled patients who underwent primary angioplasty within 6 hours after symptoms&#xD;
      onset, were introduced antiplatelet and anticoagulation therapy at the correct dose,&#xD;
      respectively Acetylsalicylic Acid (ASA) 200 mg and Clopidogrel 300 mg, and enoxaparin 30 mg.&#xD;
      In patients without contraindication, it will be administered in the first 24 hours&#xD;
      beta-blockers and ACEi in those with ejection fraction (EF) &lt;0.4, previous MI or prior heart&#xD;
      failure. Upon admission, if there is no contraindication, simvastatin 40 mg/day will be&#xD;
      administered. As a maintenance dose, the investigators will administer ASA 100 mg,&#xD;
      clopidogrel 75 mg, enoxaparin 1 mg/kg twice daily, simvastatin 40 mg, propranolol 40 mg or&#xD;
      metoprolol 50 mg (beta-blockers available at the hospital) and captopril 25 mg (most used&#xD;
      ACEi). Patients will be treated preferably in the Coronary Unit (CU). Researchers may suggest&#xD;
      the physician responsible for the patient care to prescribe the above medications, as well as&#xD;
      question why the drugs listed in the guidelines are not being used. The reasons and specific&#xD;
      contraindications will be recorded.&#xD;
&#xD;
      The researchers are not directly responsible for the treatment of individuals, which does not&#xD;
      absolve them of responsibility for any adverse effects related to the experiments. Also, the&#xD;
      investigators emphasize that the study did not interfere with the flow of patients during&#xD;
      hospitalization, i.e., will not influence the discharge of patients.&#xD;
&#xD;
      Randomization to one of the three clamps&#xD;
&#xD;
      As observed, the investigators will evaluate endothelial reactivity by FMD. On the day of the&#xD;
      clamp, after fasting, they will be exposed to one of three situations: (i) hyperglycemia /&#xD;
      hypoinsulinemia, (ii) euglycaemia / hyperinsulinemia and (iii) hyperglycemia /&#xD;
      hyperinsulinemia.&#xD;
&#xD;
      The clamps will simulate the possible attenuation or increase in endothelial reactivity&#xD;
      promoted by the independent variables during ischemia/reperfusion (I/R) injury. In total, the&#xD;
      test will consist of realization of a basal FMD-1 (during 15 minutes), clamps (variable&#xD;
      length, usually 60 minutes), FMD-2 (15 min) after the clamp, rest time (30 min),&#xD;
      ischemia/reperfusion (20 min) injury, rest time (15 min) and FMD-3 (15 min). Throughout the&#xD;
      experiment, blood glucose and insulin will be controlled and maintained at levels such as&#xD;
      designed previously for each clamp situation. In all subjects, plasma samples will be&#xD;
      collected before the start of the clamp (during FMD-1), at the end of the measurement of the&#xD;
      second FMD during the clamp, prior to the I/R injury and 15 minutes after the end of the same&#xD;
      test (during FMD-3). In these samples will be dosed insulin, glucose, C-peptide, C-reactive&#xD;
      protein, tumor necrosis factor-α (TNF-α), nitric oxide, intercellular adhesion molecule-1&#xD;
      (ICAM-1), plasminogen activator inhibition-1 (PAI-1), isoprostane and interleucin-1 (IL-1).&#xD;
&#xD;
      In one group, the euglycemic/hyperinsulinemic consists of a situation in which insulin levels&#xD;
      are above physiological levels and blood glucose levels maintained at approximately 100&#xD;
      mg/dL. Euglycemic/hyperinsulinemic clamp is similar to the way the&#xD;
      hyperinsulinemic/hyperglycemic clamp is performed, although reaching a glucose level of&#xD;
      approximately 150 mg/dL. During the clamp with hypoinsulinemia/hyperglycemia, will be infused&#xD;
      a somatostatin analogue (octreotide) for 30 minutes (t = 0 min) and subsequently infusion of&#xD;
      20% glucose to achieve glycaemia of approximately 150 mg/dL (t = 30 min).&#xD;
&#xD;
      Ischemia/Reperfusion Injury The I/R injury is intended to simulate at the brachial artery a&#xD;
      condition similar to coronary lesion resulting from infarction after reperfusion. This&#xD;
      experiment will be performed 30 min after the measurement of FMD-2, positioning a pneumatic&#xD;
      cuff at level of brachial artery, inflating it to 200 mmHg for 15 minutes. After this period&#xD;
      of ischemia, the cuff is deflated and is subsequently performed the brachial reactivity test.&#xD;
      This ischemia period is safe, as shown in other studies.&#xD;
&#xD;
      Statistical analysis Data will presented as mean ± standard deviation (SD) when normally&#xD;
      distributed or median and interquartile range (IQR) for non-normal data. Categorical&#xD;
      variables will be compared by chi-square. Continuous variables with normal distribution will&#xD;
      be compared using analysis of covariance (ANCOVA) adjusted for age, gender, size of MI&#xD;
      estimated by peak CK-MB and estimated by heart rate variability sympathetic activity.&#xD;
      Prerequisites for the ANCOVA models (linearity, normality and equal variance) will be checked&#xD;
      using histograms, normal probability plots and residual dispersion. Non-normal continuous&#xD;
      variables may be transformed logarithmically. If, after the transformation, they persist not&#xD;
      normal, will be analyzed by the Kruskal-Wallis test. Analysis will be performed using the&#xD;
      SPSS 22 application, Mac version.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">February 2016</completion_date>
  <primary_completion_date type="Anticipated">February 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in endothelial function after ischemia/reperfusion injury</measure>
    <time_frame>Between 144 and 168 h after Myocardial Infarction</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma pool of nitric oxide after ischemia/reperfusion injury</measure>
    <time_frame>Between 144 and 168 h after Myocardial Infarction</time_frame>
    <description>Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on nitric oxide generation before and after ischemia/reperfusion injury assessed at brachial artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory markers after ischemia/reperfusion injury</measure>
    <time_frame>Between 144 and 168 h after Myocardial Infarction</time_frame>
    <description>Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of inflammatory activity (CRP, TNF alpha, IL-1 beta and IL-10) in after ischemia/reperfusion injury assessed at brachial artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biomarkers of endothelial dysfunction before and after ischemia/reperfusion injury</measure>
    <time_frame>Between 144 and 168 h after MI</time_frame>
    <description>Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of endothelial activation (ICAM-1, VCAM-1, PAI-1) in after ischemia/reperfusion injury assessed at brachial artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biomarkers of oxidative stress before and after ischemia/reperfusion injury</measure>
    <time_frame>Between 144 and 168h after MI</time_frame>
    <description>Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of oxidative stress (nitrotyrosine and 8-isoprostane) before and after ischemia/reperfusion injury assessed at brachial artery</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Hyperinsulinemia/Euglycaemia</arm_group_label>
    <description>In this group study, a condition of Hyperinsulinemia/Euglycaemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperinsulinemia/Hyperglycemia</arm_group_label>
    <description>In this group study, a condition of Hyperinsulinemia/Hyperglycemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypoinsulinemia/Hyperglycemia group</arm_group_label>
    <description>In this group study, a condition of Hypoinsulinemia/Hyperglycemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, whole blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with ST segment elevation myocardial infarction (STEMI) attended at&#xD;
        Clinics Hospital of Campinas&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  less than 12 hours from the onset of symptoms of STEMI,&#xD;
&#xD;
          -  reperfusion therapy performed less than 6 hours of symptom onset.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients that after 24 hours did not show markers of myocardial necrosis&#xD;
&#xD;
          -  diabetes or use of oral antidiabetics&#xD;
&#xD;
          -  admission with glycosylated hemoglobin ≥ 6.5%&#xD;
&#xD;
          -  patients with creatinine clearance &lt;50 ml / min,&#xD;
&#xD;
          -  patients with BMI ≥ 40 kg / m2,&#xD;
&#xD;
          -  premenopausal women,&#xD;
&#xD;
          -  patients that used nitrate or vasoactive drugs (norepinephrine, dobutamine,&#xD;
             nitroglycerin or nitroprussiate in 48h prior to the examination of endothelial&#xD;
             function&#xD;
&#xD;
          -  cardiac dysfunction in acute MI with or without repercussion clinic, diagnosed by&#xD;
             ejection fraction less than 50% left ventricle.&#xD;
&#xD;
          -  FMD values above or below 2 standard deviations or more from the average of these&#xD;
             tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrei C Sposito, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiology Division, Campinas State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrei C Sposito, PhD, MD</last_name>
    <phone>+55 19 3521-7554</phone>
    <email>andreisposito@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinics Hospital</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13083-888</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrei C Sposito, PhD, MD</last_name>
      <phone>+55 19 3521-7554</phone>
      <email>brasiliaheartstudy@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Andrei C Sposito, PhD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Riobaldo R Cintra, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thiago Quinaglia, PhD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Valeria N Figueiredo, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Andrei Carvalho Sposito</investigator_full_name>
    <investigator_title>Assistent Professor, Cardiology Division</investigator_title>
  </responsible_party>
  <keyword>Endothelial disfunction</keyword>
  <keyword>Intercellular Adhesion Molecule-1</keyword>
  <keyword>Vascular Cell Adhesion Molecule-1</keyword>
  <keyword>8-epi-prostaglandin F2alpha</keyword>
  <keyword>Nitric Oxide</keyword>
  <keyword>Plasminogen Activator Inhibitor 1</keyword>
  <keyword>Endothelin-1</keyword>
  <keyword>Tumor Necrosis Factor-alpha</keyword>
  <keyword>Glucose</keyword>
  <keyword>Insulin</keyword>
  <keyword>C-peptide</keyword>
  <keyword>C-reactive protein</keyword>
  <keyword>3-nitrotyrosine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02250989
org study id: Ateroloab-1
nct id: NCT02250989
lead sponsor: 
has dmc: Yes
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
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.

      The researchers are not directly responsible for the treatment of individuals, which does not
      absolve them of responsibility for any adverse effects related to the experiments. Also, the
      investigators emphasize that the study did not interfere with the flow of patients during
      hospitalization, i.e., will not influence the discharge of patients.

      Randomization to one of the three clamps

      As observed, the investigators will evaluate endothelial reactivity by FMD. On the day of the
      clamp, after fasting, they will be exposed to one of three situations: (i) hyperglycemia /
      hypoinsulinemia, (ii) euglycaemia / hyperinsulinemia and (iii) hyperglycemia /
      hyperinsulinemia.

      The clamps will simulate the possible attenuation or increase in endothelial reactivity
      promoted by the independent variables during ischemia/reperfusion (I/R) injury. In total, the
      test will consist of realization of a basal FMD-1 (during 15 minutes), clamps (variable
      length, usually 60 minutes), FMD-2 (15 min) after the clamp, rest time (30 min),
      ischemia/reperfusion (20 min) injury, rest time (15 min) and FMD-3 (15 min). Throughout the
      experiment, blood glucose and insulin will be controlled and maintained at levels such as
      designed previously for each clamp situation. In all subjects, plasma samples will be
      collected before the start of the clamp (during FMD-1), at the end of the measurement of the
      second FMD during the clamp, prior to the I/R injury and 15 minutes after the end of the same
      test (during FMD-3). In these samples will be dosed insulin, glucose, C-peptide, C-reactive
      protein, tumor necrosis factor-α (TNF-α), nitric oxide, intercellular adhesion molecule-1
      (ICAM-1), plasminogen activator inhibition-1 (PAI-1), isoprostane and interleucin-1 (IL-1).

      In one group, the euglycemic/hyperinsulinemic consists of a situation in which insulin levels
      are above physiological levels and blood glucose levels maintained at approximately 100
      mg/dL. Euglycemic/hyperinsulinemic clamp is similar to the way the
      hyperinsulinemic/hyperglycemic clamp is performed, although reaching a glucose level of
      approximately 150 mg/dL. During the clamp with hypoinsulinemia/hyperglycemia, will be infused
      a somatostatin analogue (octreotide) for 30 minutes (t = 0 min) and subsequently infusion of
      20% glucose to achieve glycaemia of approximately 150 mg/dL (t = 30 min).

      Ischemia/Reperfusion Injury The I/R injury is intended to simulate at the brachial artery a
      condition similar to coronary lesion resulting from infarction after reperfusion. This
      experiment will be performed 30 min after the measurement of FMD-2, positioning a pneumatic
      cuff at level of brachial artery, inflating it to 200 mmHg for 15 minutes. After this period
      of ischemia, the cuff is deflated and is subsequently performed the brachial reactivity test.
      This ischemia period is safe, as shown in other studies.

      Statistical analysis Data will presented as mean ± standard deviation (SD) when normally
      distributed or median and interquartile range (IQR) for non-normal data. Categorical
      variables will be compared by chi-square. Continuous variables with normal distribution will
      be compared using analysis of covariance (ANCOVA) adjusted for age, gender, size of MI
      estimated by peak CK-MB and estimated by heart rate variability sympathetic activity.
      Prerequisites for the ANCOVA models (linearity, normality and equal variance) will be checked
      using histograms, normal probability plots and residual dispersion. Non-normal continuous
      variables may be transformed logarithmically. If, after the transformation, they persist not
      normal, will be analyzed by the Kruskal-Wallis test. Analysis will be performed using the
      SPSS 22 application, Mac version.
observational model: Cohort
time perspective: Prospective
measure: Change in endothelial function after ischemia/reperfusion injury
time frame: Between 144 and 168 h after Myocardial Infarction
description: 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.
measure: Change in plasma pool of nitric oxide after ischemia/reperfusion injury
time frame: Between 144 and 168 h after Myocardial Infarction
description: Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on nitric oxide generation before and after ischemia/reperfusion injury assessed at brachial artery.
measure: Change in inflammatory markers after ischemia/reperfusion injury
time frame: Between 144 and 168 h after Myocardial Infarction
description: Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of inflammatory activity (CRP, TNF alpha, IL-1 beta and IL-10) in after ischemia/reperfusion injury assessed at brachial artery.
measure: Change in biomarkers of endothelial dysfunction before and after ischemia/reperfusion injury
time frame: Between 144 and 168 h after MI
description: Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of endothelial activation (ICAM-1, VCAM-1, PAI-1) in after ischemia/reperfusion injury assessed at brachial artery.
measure: Change in biomarkers of oxidative stress before and after ischemia/reperfusion injury
time frame: Between 144 and 168h after MI
description: Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of oxidative stress (nitrotyrosine and 8-isoprostane) before and after ischemia/reperfusion injury assessed at brachial artery
arm group label: Hyperinsulinemia/Euglycaemia
description: In this group study, a condition of Hyperinsulinemia/Euglycaemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.
arm group label: Hyperinsulinemia/Hyperglycemia
description: In this group study, a condition of Hyperinsulinemia/Hyperglycemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.
arm group label: Hypoinsulinemia/Hyperglycemia group
description: In this group study, a condition of Hypoinsulinemia/Hyperglycemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.
Plasma, whole blood.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Andrei C Sposito, PhD, MD
role: Principal Investigator
affiliation: Cardiology Division, Campinas State University
last name: Andrei C Sposito, PhD, MD
phone: +55 19 3521-7554
email: andreisposito@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Andrei Carvalho Sposito
investigator title: Assistent Professor, Cardiology Division
mesh term: Myocardial Infarction
mesh term: Infarction