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

C

Chinese PLA General Hospital (301 Hospital)

Status

Unknown

Conditions

Myocardial Infarction

Treatments

Drug: GLP-1
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02577848
GLP-1-301xnk

Details and patient eligibility

About

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

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups, including a placebo group

GLP-1 group
Experimental group
Description:
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.
Treatment:
Drug: GLP-1
placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Wei Ren Chen, M.D.

Data sourced from clinicaltrials.gov

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