Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-01-29 @ 6:07 PM
Study NCT ID:
NCT02507128
Status:
UNKNOWN
Last Update Posted:
2015-07-23
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Glucagon Like Peptide-1 on No-reflow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'differences in the incidences of treatment-emergent adverse events', 'timeFrame': 'immediately after PCI, at 1,3,5 days after PCI', 'description': 'Treatment-emergent adverse events (TEAEs): hypoglycaemia, pancreatitis, thyroid cancer'}], 'primaryOutcomes': [{'measure': 'a change in the prevalence of no-reflow', 'timeFrame': 'immediately after PCI', 'description': 'The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.'}], 'secondaryOutcomes': [{'measure': 'a change in troponin T', 'timeFrame': 'immediately after PCI, at 1,3,5 days after PCI', 'description': 'Secondary efficacy variable was troponin T level.'}, {'measure': 'a change in high-sensitivity C-reactive protein (hsCRP)', 'timeFrame': 'immediately after PCI, at 1,3,5 days after PCI', 'description': 'Secondary efficacy variable was high-sensitivity C-reactive protein level.'}, {'measure': 'a change in superoxide dismutase (SOD)', 'timeFrame': 'immediately after PCI, at 1,3,5 days after PCI', 'description': 'Secondary efficacy variable was superoxide dismutase level.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute ST-segment Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '12517460', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1016/S0140-6736(03)12113-7.'}, {'pmid': '11997276', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1161/01.cir.0000014683.52177.b5.'}, {'pmid': '19021281', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23506504', 'type': 'BACKGROUND', 'citation': 'Muller O, Trana C, Eeckhout E. Myocardial no-reflow treatment. Curr Vasc Pharmacol. 2013 Mar 1;11(2):278-85.'}, {'pmid': '19195607', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).', 'detailedDescription': "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.\n\nGlucagon-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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with ST-segment elevation myocardial infarction were eligible for the study.\n\nExclusion Criteria:\n\nPatients 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.'}, 'identificationModule': {'nctId': 'NCT02507128', 'briefTitle': 'Effects of Glucagon Like Peptide-1 on No-reflow', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': '301xnk'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLP-1 group', 'description': 'The treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance).', 'interventionNames': ['Drug: liraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'the treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance).', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'otherNames': ['glucagon like peptide-1'], 'description': 'Liraglutide were taken 30 min before PCI.', 'armGroupLabels': ['GLP-1 group']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo were taken 30 min before PCI.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Ren Chen, M.D.', 'role': 'CONTACT', 'email': 'chen_weiren@sina.com', 'phone': '+8610-66939709'}, {'name': 'Yun Dai Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'wei ren chen, M.D.', 'role': 'CONTACT', 'email': 'chen_weiren@sina.com', 'phone': '+8601066876221'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chen Wei Ren, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Chen Wei Ren, MD', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}