Effects of Glucagon Like Peptide-1 on No-reflow
Information source: Chinese PLA General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute ST-segment Elevation Myocardial Infarction
Intervention: liraglutide (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Chen Wei Ren, MD Overall contact: wei ren chen, M.D., Phone: +8601066876221, Email: chen_weiren@sina.com
Summary
The investigators planned to evaluate the effects of liraglutide on no-reflow in patients
with acute ST-segment elevation myocardial infarction (STEMI).
Clinical Details
Official title: Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: a change in the prevalence of no-reflow
Secondary outcome: a change in troponin Ta change in high-sensitivity C-reactive protein (hsCRP) a change in superoxide dismutase (SOD)
Detailed description:
Acute myocardial infarction (AMI) is a major cause of mortality and morbidity. Primary
percutaneous coronary intervention (PCI) is currently the most effective treatment strategy
for AMI. Brisk thrombolysis in myocardial infarction (TIMI) grade 3 flow immediately after
PCI in patients with AMI is associated with improved clinical outcomes compared with lower
flow grades. However, myocardial reperfusion is suboptimal in many patients, mostly because
of the 'no-reflow' phenomenon. No-reflow is defined as suboptimal myocardial reperfusion in
part of the coronary circulation without angiographic evidence of mechanical vessel
obstruction. To date, however, very few drugs have been shown to reverse established
no-reflow.
Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and
GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction.
GLP-1 has antioxidant and anti-inflammatory properties, and may protect endothelial
function. Experimental studies have also revealed that GLP-1 or its analogues protect
against reperfusion injury in pigs. Exenatide, a GLP-1 analogue, was reported to reduce
reperfusion injury in patients with ST-segment elevation myocardial infarction. Similarly,
liraglutide was reported to reduce cardiac rupture and infarct size and improve cardiac
output in normal and diabetic mice. To date, however, there is no clinical evidence for the
effects of liraglutide on no-reflow in patients with AMI. Therefore, the aim of this study
was to evaluate the effects of liraglutide pretreatment on myocardial no-reflow of prime PCI
in patients with AMI.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients with ST-segment elevation myocardial infarction were eligible for the study.
Exclusion Criteria:
Patients were excluded for the following reasons: unconscious at presentation; had
cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial
infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary
artery bypass surgery.
Locations and Contacts
wei ren chen, M.D., Phone: +8601066876221, Email: chen_weiren@sina.com
PLA General Hospital, Beijing, Beijing 100853, China; Recruiting Wei Ren Chen, M.D., Phone: +8610-66939709, Email: chen_weiren@sina.com Yun Dai Chen, M.D., Principal Investigator
Additional Information
Related publications: Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. Review. Gibson CM, Cannon CP, Murphy SA, Marble SJ, Barron HV, Braunwald E; TIMI Study Group. Relationship of the TIMI myocardial perfusion grades, flow grades, frame count, and percutaneous coronary intervention to long-term outcomes after thrombolytic administration in acute myocardial infarction. Circulation. 2002 Apr 23;105(16):1909-13. Rezkalla SH, Kloner RA. Coronary no-reflow phenomenon: from the experimental laboratory to the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2008 Dec 1;72(7):950-7. doi: 10.1002/ccd.21715. Review. Muller O, Trana C, Eeckhout E. Myocardial no-reflow treatment. Curr Vasc Pharmacol. 2013 Mar 1;11(2):278-85. Review. Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G, Hoefer IE. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. J Am Coll Cardiol. 2009 Feb 10;53(6):501-10. doi: 10.1016/j.jacc.2008.10.033.
Starting date: July 2015
Last updated: July 22, 2015
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