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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577848
Recruitment Status : Unknown
Verified October 2015 by Chen Wei Ren, MD, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : October 16, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Chen Wei Ren, MD, Chinese PLA General Hospital

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).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: GLP-1 Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Liraglutide on Left Ventricular Function in Patients With Non-ST-Segment Elevation Myocardial Infarction
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: GLP-1 group
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
GLP-1 were taken daily for 7 days
Other Name: Liraglutide

Placebo Comparator: placebo
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
Placebo were taken daily for 7 days




Primary Outcome Measures :
  1. left ventricular ejection fractions [ Time Frame: at 3 months ]
    The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by transthoracic echocardiography at 3 months .


Secondary Outcome Measures :
  1. 6-minute walk distance [ Time Frame: at 3 months ]
    The change in6-minute walk distance at 3 months after treatment.

  2. treatment-emergent adverse events [ Time Frame: at 3 months ]
    Treatment-emergent adverse events (TEAEs): hypoglycaemia, pancreatitis, thyroid cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577848


Contacts
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Contact: Wei Ren Chen, M.D. +8610-66876231 chen_weiren@sina.com

Locations
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China, Beijing
PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Yang Shi, M.D.    +8610-66876231    ggyyong@sina.com   
Principal Investigator: Yu Tang Wang, M.D.         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: zhu Chen World Health Organization
Publications:

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Responsible Party: Chen Wei Ren, MD, Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02577848    
Other Study ID Numbers: GLP-1-301xnk
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015
Keywords provided by Chen Wei Ren, MD, Chinese PLA General Hospital:
Glucagon-like peptide-1
Non-ST-segment elevation myocardial infarction
Left ventricular ejection fraction
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists