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

NCT ID: NCT02577848

Last Updated: 2015-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

GLP-1

Intervention Type DRUG

GLP-1 were taken daily for 7 days

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo were taken daily for 7 days

Interventions

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GLP-1

GLP-1 were taken daily for 7 days

Intervention Type DRUG

Placebo

Placebo were taken daily for 7 days

Intervention Type DRUG

Other Intervention Names

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Liraglutide

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Wei Ren, MD

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zhu Chen

Role: PRINCIPAL_INVESTIGATOR

World Health Organization

Locations

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PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Ren Chen, M.D.

Role: CONTACT

+8610-66876231

Facility Contacts

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Yang Shi, M.D.

Role: primary

+8610-66876231

References

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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.

Reference Type BACKGROUND
PMID: 23991622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17392556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21920963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23564922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15356213 (View on PubMed)

Other Identifiers

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GLP-1-301xnk

Identifier Type: -

Identifier Source: org_study_id

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