Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-21 @ 11:48 AM
Study NCT ID:
NCT02239757
Status:
COMPLETED
Last Update Posted:
2015-08-03
First Post:
2014-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-30', 'studyFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vascular complications', 'timeFrame': '7 days', 'description': 'Vascular complications include pseudoaneurysm, arteriovenous fistula, lose of radial artery pulse, puncture site bleeding and forearm hematoma.'}], 'primaryOutcomes': [{'measure': 'Needle to balloon time', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Radiation dose', 'timeFrame': '7 days', 'description': 'Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)'}, {'measure': 'Fluoroscopy time', 'timeFrame': '7 days'}, {'measure': 'Contrast volume', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction'], 'conditions': ['Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '25018624', 'type': 'BACKGROUND', 'citation': 'Hu H, Fu Q, Chen W, Wang D, Hua X, Chen B. A prospective randomized comparison of left and right radial approach for percutaneous coronary angiography in Asian populations. Clin Interv Aging. 2014 Jun 20;9:963-8. doi: 10.2147/CIA.S64235. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion time has not been fully studied for SETMI patients undergoing primary percutaneous coronary intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety of left radial approach for primary PCI in STEMI patients compared with right radial approach.', 'detailedDescription': 'The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary PCI.\n\nPatients will be included within 12 hours of symptom onset for primary PCI. Patients will be excluded if they are in cardiogenic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll consecutive patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset for primary PCI.\n\nExclusion Criteria:\n\nPatients are excluded if they were in cardiogenic shock.'}, 'identificationModule': {'nctId': 'NCT02239757', 'briefTitle': 'Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'orgStudyIdInfo': {'id': 'LERRASMI'}, 'secondaryIdInfos': [{'id': 'Lerrasmi', 'type': 'REGISTRY', 'domain': 'Lerrasmi'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Right radial approach', 'description': 'Primary PCI performed through right radial approach.', 'interventionNames': ['Procedure: Left radial approach']}, {'type': 'EXPERIMENTAL', 'label': 'Left radial approach', 'description': 'Primary PCI performed through left radial approach.', 'interventionNames': ['Procedure: Right radial approach']}], 'interventions': [{'name': 'Left radial approach', 'type': 'PROCEDURE', 'description': 'Primary PCI performed through left radial approach.', 'armGroupLabels': ['Right radial approach']}, {'name': 'Right radial approach', 'type': 'PROCEDURE', 'description': 'Primary PCI performed through right radial approach.', 'armGroupLabels': ['Left radial approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Buxing Chen, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of department of cardiology', 'investigatorFullName': 'Buxing Chen', 'investigatorAffiliation': 'Capital Medical University'}}}}