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Impact of Glycemic State on Patients ST Elevation Myocardial Infarction With Primary Percutaneous Coronary Angioplasty

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ClinicalTrials.gov Identifier: NCT03266978
Recruitment Status : Unknown
Verified August 2017 by El shaimaa Abd El Fattah Omran, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
El shaimaa Abd El Fattah Omran, Assiut University

Brief Summary:
ST-elevation myocardial infarction is a major cause of morbidity and mortality worldwide. ST-elevation myocardial infarction damages the regional myocardium that undergoes ischemia and necrosis, resulting in impairment of both systolic and diastolic functions of the heart. Left ventricular function and myocardial infarct size both serve as the main determinants Of patients' outcome after myocardial infarction. Timely management of ST-elevation myocardial infarction, using reperfusion therapy, including fibrinolysis and primary percutaneous coronary intervention, leads to a better outcome for these patients.

Condition or disease
ST Elevation Myocardial Infarction

Detailed Description:

Reperfusion failure is attributed to different factors, including diabetes. Several mechanisms have been proposed for the harmful effects of hyperglycemia after acute myocardial infarction. Association of hyperglycemia with the activation of blood coagulation has been well studied; it could induce a shortening of the fibrinogen half-life, increase in fibrinopeptide A, fragments of pro-thrombin in factor VII, and platelet aggregation, all of which could lead to increased activation of thrombosis. Hyperglycemia at admission is associated with increased levels of inflammatory markers, enhanced expression of cytotoxic T-cells, and reduced expression of cytotoxic T-lymphocyte-associated protein 4, indicating its association with increased inflammatory immune process after acute myocardial infarction. It also could be associated with endothelial dysfunction, oxidative stress, and possibly, abolition of protective ischemic preconditioning. Other possible mechanism of harmful effects of acute hyperglycemia is microvascular dysfunction after coronary revascularization.

Studying the influence of diabetes mellitus on clinical outcome in the thrombolytic era of acute myocardial infarction, GUSTO-I trial showed that patients with diabetes mellitus have a significantly increased risk of both early and late mortality, which may be attributed to more advanced coronary artery disease and co-morbidities.

Results of the HORIZONS-AMI study showed that patients with newly diagnosed diabetes mellitus had similarly poor prognosis after primary percutaneous coronary intervention in ST-elevation myocardial infarction patients as those with previously established diabetes mellitus, newly diagnosed diabetes mellitus was based on HgbA1c levels following admission and did not assess for blood glucose levels at admission or during hospital stay.

Regarding the effect of diabetes mellitus on left ventricular systolic function, diabetic patients with first ST-elevation myocardial infarction had reduced left ventricular systolic function, measured with speckle-tracking strain, compared with non-diabetic patients at baseline and at 6-month follow up, despite similar left ventricular ejection fraction in both groups. Similarly, according to the ischemic cascade, diastolic function is expected to be affected with variable degrees among diabetic, prediabetic and non-diabetic ST-elevation myocardial infarction patients.

Timmer et al, studied the effect of admission stress hyperglycemia and that of chronic hyperglycemia (elevated levels of HbA1c in patients with undiagnosed diabetes mellitus) on ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention; both elevated glucose and HbA1c levels were associated with adverse outcomes. However elevated glucose but not elevated HbA1c was associated with larger enzymatic infarct size and high early mortality.

Furthermore, Ota et al, demonstrated the association between stress hyperglycemia and the development of microvascular obstruction using late gadolinium enhancement - cardiovascular magnetic resonance imaging, suggesting that hyperglycemic control immediately after admission might reduce the incidence of microvascular obstruction.

This study is designed to explore the impact of the glycemic state on the in-hospital and short term outcomes of patients with ST-elevation myocardial infarction undergoing reperfusion therapy in two separate arms; those with known diabetes mellitus and those without known diagnosis of diabetes mellitus, and then comparing results among those with controlled diabetes mellitus, uncontrolled diabetes mellitus and newly diagnosed diabetes mellitus.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Glycemic State on the in Hospital and Short Term Outcomes of Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Angioplasty
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Admission glucose level [ Time Frame: Baseline . ]
    Blood glucose level on admission measured by mmol/l .


Secondary Outcome Measures :
  1. To evaluate left ventricular systolic function. [ Time Frame: Baseline and latter at 6 months follow-up. ]
    Using transthoracic echocardiography.

  2. To evaluate left ventricular diastolic function. [ Time Frame: Baseline and latter at 6 months follow-up. ]
    Using transthoracic echocardiography.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients presenting to investigators Coronary Care Unit - Assiut University Heart Center with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Criteria

Inclusion Criteria:

  • The study will be performed on acute ST-elevation myocardial infarction patients with/without history of diabetes mellitus undergoing primary percutaneous coronary intervention.

Exclusion Criteria:

  • Patients not treated with primary percutaneous coronary intervention.
  • Patients with prior myocardial infarction, prior primary percutaneous coronary intervention and/or coronary artery bypass graft (altering disease state).
  • Patients with cardiogenic shock (altering disease state).
  • Patients with severe liver or renal disease (altering disease state).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266978


Contacts
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Contact: Amr Youssef, MD 00201006554042 amryoussef111@yahoo.com
Contact: Mahmoud Abd Allah, MD 00201001202779 m_abd_elsabour@yahoo.com

Locations
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Egypt
Assiut University Not yet recruiting
Assiut, Egypt, 71111
Contact: Heba Elnaggar, MD    01001963100    heba_m_elnaggar@yahoo.com   
Sponsors and Collaborators
Assiut University

Publications of Results:

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Responsible Party: El shaimaa Abd El Fattah Omran, pricipal investgator, Assiut University
ClinicalTrials.gov Identifier: NCT03266978     History of Changes
Other Study ID Numbers: ODMI Assiut
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases