Effects of Glucagon Like Peptide-1 on No-reflow

Study Overview
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Brief Summary
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The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).

Detailed Description
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Acute myocardial infarction (AMI) is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (PCI) is currently the most effective treatment strategy for AMI. Brisk thrombolysis in myocardial infarction (TIMI) grade 3 flow immediately after PCI in patients with AMI is associated with improved clinical outcomes compared with lower flow grades. However, myocardial reperfusion is suboptimal in many patients, mostly because of the 'no-reflow' phenomenon. No-reflow is defined as suboptimal myocardial reperfusion in part of the coronary circulation without angiographic evidence of mechanical vessel obstruction. To date, however, very few drugs have been shown to reverse established no-reflow. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction. GLP-1 has antioxidant and anti-inflammatory properties, and may protect endothelial function. Experimental studies have also revealed that GLP-1 or its analogues protect against reperfusion injury in pigs. Exenatide, a GLP-1 analogue, was reported to reduce reperfusion injury in patients with ST-segment elevation myocardial infarction. Similarly, liraglutide was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. To date, however, there is no clinical evidence for the effects of liraglutide on no-reflow in patients with AMI. Therefore, the aim of this study was to evaluate the effects of liraglutide pretreatment on myocardial no-reflow of prime PCI in patients with AMI.

Official Title
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Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Conditions
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Acute ST-segment Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ST-segment elevation myocardial infarction were eligible for the study. Exclusion Criteria: Patients were excluded for the following reasons: unconscious at presentation; had cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary artery bypass surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1 group<br>The treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance). | Drug: liraglutide<br>* Liraglutide were taken 30 min before PCI.<br>* Other names: glucagon like peptide-1;|
| Placebo Comparator: Control group<br>the treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance). | Drug: placebo<br>* Placebo were taken 30 min before PCI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in the prevalence of no-reflow | The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure. | immediately after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in troponin T | Secondary efficacy variable was troponin T level. | immediately after PCI, at 1,3,5 days after PCI | 
| a change in high-sensitivity C-reactive protein (hsCRP) | Secondary efficacy variable was high-sensitivity C-reactive protein level. | immediately after PCI, at 1,3,5 days after PCI | 
| a change in superoxide dismutase (SOD) | Secondary efficacy variable was superoxide dismutase level. | immediately after PCI, at 1,3,5 days after PCI |