Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT01663194
Status:
COMPLETED
Last Update Posted:
2012-08-14
First Post:
2012-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neutrophil/Lymphocyte (N/L) Ratio and Long Term Follow-up in ST-elevation Myocardial Infarction
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum and plasma of blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1034}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-13', 'studyFirstSubmitDate': '2012-08-09', 'studyFirstSubmitQcDate': '2012-08-10', 'lastUpdatePostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['N/L ratio, STEMI, primary PCI, Long-term mortality'], 'conditions': ['ST Elevated Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with adverse outcomes among patients with coronary artery disease, its role during the acute phase of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This study sought to investigate the association of the pre-procedural N/L ratio within-hospital and long-term outcomes among STEMI patients undergoing primary percutaneous coronary intervention (PCI).', 'detailedDescription': 'Inflammation plays a role in the initiation and progression of the atherosclerotic process. Due to a growing recognition of its role, recent studies have focused on inflammatory markers and their association with outcomes in patients with ST-segment elevation myocardial infarction (STEMI). Recently, our single center study demonstrated that preprocedural neutrophil/lymphocyte (N/L) ratio is an independent predictor of impaired coronary flow after primary percutaneous coronary intervention (PCI) and of in-hospital major advanced cardiac events (MACE) in patients with STEMI.Several previous studies also evaluated the role of N/L ratio in long-term outcomes among patients with STEMI; however, they evaluated the association between long-term mortality and in-hospital N/L ratio, they were single-center studies and they evaluated a relatively small study population.\n\nIn the present multicenter experience, the investigators aimed to investigate the association of the preprocedural N/L ratio with the in-hospital and long-term outcomes in patients with STEMI undergoing primary PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'STEMI patients who were admitted within 6 hours from symptom onset and who underwent primary PCI were prospectively included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nST elevated myocardial infarction\n\nExclusion Criteria:\n\nTreatment with fibrinolytic drugs in the previous 24 hours Active infection Previously documented history of a systemic inflammatory process Known malignancy End-stage liver disease Renal failure'}, 'identificationModule': {'nctId': 'NCT01663194', 'briefTitle': 'Neutrophil/Lymphocyte (N/L) Ratio and Long Term Follow-up in ST-elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Observational Study of N/L Ratio in Patients With STEMI', 'orgStudyIdInfo': {'id': 'mgkaya-makpek'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'N/L ratio tertile 2', 'description': 'patients were divided in to the tertiles', 'interventionNames': ['Procedure: primary percutaneous coronary intervention, each groups']}, {'label': 'N/L ratio tertile 3', 'description': 'patients were divided in to the tertiles', 'interventionNames': ['Procedure: primary percutaneous coronary intervention, each groups']}, {'label': 'N/L ratio tertile 1', 'description': 'patients were divided in to the tertiles', 'interventionNames': ['Procedure: primary percutaneous coronary intervention, each groups']}], 'interventions': [{'name': 'primary percutaneous coronary intervention, each groups', 'type': 'PROCEDURE', 'description': 'All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).', 'armGroupLabels': ['N/L ratio tertile 1', 'N/L ratio tertile 2', 'N/L ratio tertile 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University school of medicine', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Mahmut Akpek, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Erciyes University school of medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor of cardiology department', 'investigatorFullName': 'Mahmut Akpek', 'investigatorAffiliation': 'TC Erciyes University'}}}}