Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-05 @ 10:45 PM
Study NCT ID:
NCT03272451
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-31', 'studyFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2017-09-01', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MACE', 'timeFrame': '12 month', 'description': 'major advance cardiac event (MACE)including cardiacdeath, myocardial infarction (MI) and target vessel revascularization (TVR)'}], 'primaryOutcomes': [{'measure': 'door to device (D2D) time', 'timeFrame': '24hours', 'description': "time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use"}], 'secondaryOutcomes': [{'measure': 'puncture to device (P2D) time', 'timeFrame': '24hours', 'description': 'time from radail artery puncture to first device(balloon,aspiration catheter or stent) use'}, {'measure': 'first medical contact to device (FMC2D) time', 'timeFrame': '24hours', 'description': 'time from first medical contact to first device (balloon,aspiration catheter or stent) use.'}, {'measure': 'incidence of radial artery spasm', 'timeFrame': 'during the procedure (time from the guide catheter inserted to guide catheter removed)', 'description': 'radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure'}, {'measure': 'incidence of radial artery occlusion', 'timeFrame': 'inhospital (an expected average of 5 days),30day,12month', 'description': 'the absence of palpable radial artery pulsation confirmed by echocardiogram'}, {'measure': 'fluoroscopy time', 'timeFrame': '1 hour', 'description': 'recorded on the machine'}, {'measure': 'cumulative air kerma(CAK) and dose area product(DAP).', 'timeFrame': '1 hour', 'description': 'recorded on the machine'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '36386357', 'type': 'DERIVED', 'citation': 'Guo J, Wang G, Li Z, Liu Z, Wang Y, Wang S, Wang Y, Wu Y, Wang H, Wang Y, Zhang L, Hua Q. Culprit vessel revascularization first with primary use of a dedicated transradial guiding catheter to reduce door to balloon time in primary percutaneous coronary intervention. Front Cardiovasc Med. 2022 Oct 28;9:1022488. doi: 10.3389/fcvm.2022.1022488. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by PCI for the treatment of ST segment elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D) time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy time, cumulative air kerma(CAK) and dose area product(DAP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be \\> 18 years of age\n* Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI\n* Symptoms ≥ 30 min and ≤12 hours\n* Patient and treating interventional cardiologist agree for randomization\n* Patient provides written informed consent\n* Diagnostic and therapeutic intervention performed through transradial artery approach\n* Palpable radial artery.\n\nExclusion Criteria:\n\n* Concurrent participation in other investigational study\n* Current platelet count \\<100 x 10\\^9cells/L or Hgb \\<10 g/dL\n* Absence of radial artery pulsation\n* Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy\n* Uncontrolled hypertension\n* Prior CABG surgery\n* Fibrinolytic therapy for current MI treatment\n* patient have a life expectancy of \\<180days'}, 'identificationModule': {'nctId': 'NCT03272451', 'briefTitle': 'ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Luhe Hospital'}, 'officialTitle': 'ECG-guided Immediate pRimAry Percutaneous Coronary Intervention for Culprit Vessel Using a Transradial Single Guiding Catheter to Reduce Door to Device Time: RAPID II Study', 'orgStudyIdInfo': {'id': 'BeijingLH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'culprit vessel intervention', 'description': 'culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter', 'interventionNames': ['Procedure: culprit vessel intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional approach', 'description': 'complete coronary angiography followed by guiding catheter selection for culprit vessel PCI', 'interventionNames': ['Procedure: traditional approach']}], 'interventions': [{'name': 'culprit vessel intervention', 'type': 'PROCEDURE', 'description': 'ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5', 'armGroupLabels': ['culprit vessel intervention']}, {'name': 'traditional approach', 'type': 'PROCEDURE', 'description': 'single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI', 'armGroupLabels': ['traditional approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101149', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Luhe hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Luhe hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Luhe Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}