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

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GLP-1
Placebo
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Glucagon-like peptide-1, Non-ST-segment elevation myocardial infarction, Left ventricular ejection fraction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLP-1 group

placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2015
Last Updated
October 16, 2015
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02577848
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Glucagon-like peptide-1, Non-ST-segment elevation myocardial infarction, Left ventricular ejection fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GLP-1 group
Arm Type
Experimental
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
GLP-1
Other Intervention Name(s)
Liraglutide
Intervention Description
GLP-1 were taken daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo were taken daily for 7 days
Primary Outcome Measure Information:
Title
left ventricular ejection fractions
Description
The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by transthoracic echocardiography at 3 months .
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
6-minute walk distance
Description
The change in6-minute walk distance at 3 months after treatment.
Time Frame
at 3 months
Title
treatment-emergent adverse events
Description
Treatment-emergent adverse events (TEAEs): hypoglycaemia, pancreatitis, thyroid cancer
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Ren Chen, M.D.
Phone
+8610-66876231
Email
chen_weiren@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhu Chen
Organizational Affiliation
World Health Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Shi, M.D.
Phone
+8610-66876231
Email
ggyyong@sina.com
First Name & Middle Initial & Last Name & Degree
Yu Tang Wang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
23991622
Citation
Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg JM, Miller DL, Costigan TM, Goedicke J, Silvain J, Angioli P, Legutko J, Niethammer M, Motovska Z, Jakubowski JA, Cayla G, Visconti LO, Vicaut E, Widimsky P; ACCOAST Investigators. Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes. N Engl J Med. 2013 Sep 12;369(11):999-1010. doi: 10.1056/NEJMoa1308075. Epub 2013 Sep 1.
Results Reference
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PubMed Identifier
17392556
Citation
Aronson D, Hammerman H, Kapeliovich MR, Suleiman A, Agmon Y, Beyar R, Markiewicz W, Suleiman M. Fasting glucose in acute myocardial infarction: incremental value for long-term mortality and relationship with left ventricular systolic function. Diabetes Care. 2007 Apr;30(4):960-6. doi: 10.2337/dc06-1735.
Results Reference
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PubMed Identifier
21920963
Citation
Lonborg J, Vejlstrup N, Kelbaek H, Botker HE, Kim WY, Mathiasen AB, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Thuesen L, Krusell LR, Jensen JS, Kober L, Treiman M, Holst JJ, Engstrom T. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012 Jun;33(12):1491-9. doi: 10.1093/eurheartj/ehr309. Epub 2011 Sep 14.
Results Reference
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PubMed Identifier
23564922
Citation
Ceriello A, Novials A, Ortega E, Canivell S, La Sala L, Pujadas G, Esposito K, Giugliano D, Genovese S. Glucagon-like peptide 1 reduces endothelial dysfunction, inflammation, and oxidative stress induced by both hyperglycemia and hypoglycemia in type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2346-50. doi: 10.2337/dc12-2469. Epub 2013 Apr 5.
Results Reference
background
PubMed Identifier
15356213
Citation
Nikolaidis LA, Doverspike A, Hentosz T, Zourelias L, Shen YT, Elahi D, Shannon RP. Glucagon-like peptide-1 limits myocardial stunning following brief coronary occlusion and reperfusion in conscious canines. J Pharmacol Exp Ther. 2005 Jan;312(1):303-8. doi: 10.1124/jpet.104.073890. Epub 2004 Sep 8.
Results Reference
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GLP-1 on Non-ST-Segment Elevation Myocardial Infarction

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