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

August 29, 2017 updated by: El shaimaa Abd El Fattah Omran, Assiut University

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

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.

Study Overview

Status

Unknown

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admission glucose level
Time Frame: Baseline .
Blood glucose level on admission measured by mmol/l .
Baseline .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate left ventricular systolic function.
Time Frame: Baseline and latter at 6 months follow-up.
Using transthoracic echocardiography.
Baseline and latter at 6 months follow-up.
To evaluate left ventricular diastolic function.
Time Frame: Baseline and latter at 6 months follow-up.
Using transthoracic echocardiography.
Baseline and latter at 6 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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