GLP-1 on Non-ST-Segment Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The investigators planned to evaluate the effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction (NSTEMI).

Detailed Description
-----------------
Patients with non-ST-segment elevation myocardial infarction (NSTEMI) are a heterogeneous group with respect to the risk of having a major adverse cardiac event (MACE). Elevation of blood glucose is a common metabolic disorder among patients with acute myocardial infarction (AMI) and is associated with adverse prognosis. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose. GLP-1 analogues have significant cardiovascular protective effects in patients with AMI. GLP-1 may have antioxidant and anti-inflammatory properties, and protect endothelial function. Studies in conscious, chronically instrumented dogs demonstrated that GLP-1 infusion increases insulin sensitivity and myocardial glucose uptake in postischemic contractile dysfunction and dilated cardiomyopathy. Liraglutide, a GLP-1 analogue, was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. Continuous infusion of GLP-1 (1.5 pmol/kg/min) has been shown to improve functional recovery in patients with AMI complicated by decreased left ventricular function GLP-1 could protect against ischemia-reperfusion injury and improve cardiac function in patients with acute ST-segment elevation myocardial infarction. However, the effects of GLP-1 on NSTEMI patients remain unclear. The aim of this study was to evaluate the effects of liraglutide on left ventricular function in patients with NSTEMI.

Official Title
-----------------
Effects of Liraglutide on Left Ventricular Function in Patients With Non-ST-Segment Elevation Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: GLP-1
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-ST-segment elevation myocardial infarction (NSTEMI ) Exclusion Criteria: unconscious at presentation had ST-segment elevation acute myocardial infarction NSTEMI requiring emergency percutaneous coronary angiography valvular heart disease cardiogenic shock hypoglycaemia diabetic ketoacidosis had a history of myocardial infarction stent implantation renal insufficiency had previously undergone coronary artery bypass surgery.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>liraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 7 days. After admission, the patients were treated with 0.6 mg liraglutide once daily for 2 day, then 1.2 mg liraglutide for another 2 day, and then 1.8 mg liraglutide for 3 days. | Drug: GLP-1<br>* GLP-1 were taken daily for 7 days<br>* Other names: Liraglutide;|
| Placebo Comparator: placebo<br>placebo (Novo Nordisk, Bagsværd, Denmark); the frequency: Placebo were taken daily; duration: After admission, the patients were treated with 0.6 mg placebo once daily for 2 day, then 1.2 mg placebo for another 2 day, and then 1.8 mg placebo for 3 days. | Drug: Placebo<br>* Placebo were taken daily for 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fractions | The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by transthoracic echocardiography at 3 months . | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk distance | The change in6-minute walk distance at 3 months after treatment. | at 3 months | 
| treatment-emergent adverse events | Treatment-emergent adverse events (TEAEs): hypoglycaemia, pancreatitis, thyroid cancer | at 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucagon-like peptide-1, Non-ST-segment elevation myocardial infarction, Left ventricular ejection fraction