Clinical trial NCT02577848: GLP-1 on Non-ST-Segment Elevation Myocardial Infarction
Official title: Effects of Liraglutide on Left Ventricular Function in Patients With Non-ST-Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Keywords: Glucagon-like peptide-1
Non-ST-segment elevation myocardial infarction
Left ventricular ejection fraction
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

non-ST-segment elevation myocardial infarction (NSTEMI )

Exclusion Criteria:

1. unconscious at presentation
2. had ST-segment elevation acute myocardial infarction
3. NSTEMI requiring emergency percutaneous coronary angiography
4. valvular heart disease
5. cardiogenic shock
6. hypoglycaemia
7. diabetic ketoacidosis
8. had a history of myocardial infarction
9. stent implantation
10. renal insufficiency
11. had previously undergone coronary artery bypass surgery.

Primary outcomes:
measure: left ventricular ejection fractions
timeFrame: at 3 months
Secondary outcomes:
measure: 6-minute walk distance
timeFrame: at 3 months
measure: treatment-emergent adverse events
timeFrame: at 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA General Hospital
state: Beijing
Study officials:
affiliation: World Health Organization
name: zhu Chen
role: PRINCIPAL_INVESTIGATOR
References:
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