The Influence of Glycaemia and Insulinemia on Vasomotor Endothelial Function After Myocardial Infarction

NCT02250989 | Unknown DMC

• 1 other identifier: Ateroloab-1
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocardial Infarction

Keywords

Endothelial disfunction; Intercellular Adhesion Molecule-1; Vascular Cell Adhesion Molecule-1; 8-epi-prostaglandin F2alpha; Nitric Oxide; Plasminogen Activator Inhibitor 1; Endothelin-1; Tumor Necrosis Factor-alpha; Glucose; Insulin; C-peptide; C-reactive protein; 3-nitrotyrosine

Outcome Measures

Primary Outcomes (1)

• Change in endothelial function after ischemia/reperfusion injury

  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.

  Between 144 and 168 h after Myocardial Infarction

Secondary Outcomes (4)

• Change in plasma pool of nitric oxide after ischemia/reperfusion injury

  Between 144 and 168 h after Myocardial Infarction

• 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 biomarkers of oxidative stress before and after ischemia/reperfusion injury

  Between 144 and 168h after MI

Study Arms (3)

Hyperinsulinemia/Euglycaemia

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.

Hyperinsulinemia/Hyperglycemia

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.

Hypoinsulinemia/Hyperglycemia group

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.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with ST segment elevation myocardial infarction (STEMI) attended at Clinics Hospital of Campinas

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Clinics Hospital

Campinas, São Paulo, 13083-888, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, whole blood.

MeSH Terms

Conditions

Myocardial Infarction; Insulin Resistance

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrei C Sposito, PhD, MD

  Cardiology Division, Campinas State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrei C Sposito, PhD, MD

CONTACT

+55 19 3521-7554; andreisposito@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor, Cardiology Division

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 26, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

BR (1)