Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-06 @ 3:58 AM
Study NCT ID:
NCT02606435
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2015-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombus Aspiration in Patients With STEMI
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': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-12', 'studyFirstSubmitDate': '2015-11-11', 'studyFirstSubmitQcDate': '2015-11-12', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events', 'timeFrame': '1 year', 'description': 'number of participants with cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure'}], 'secondaryOutcomes': [{'measure': 'Number of participants with stent thrombosis', 'timeFrame': '1 year', 'description': 'number of participants with stent thrombosis'}, {'measure': 'Number of participants with target vessel revascularization', 'timeFrame': '1 year', 'description': 'number of participants with target vessel revascularization'}, {'measure': 'left ventricular function', 'timeFrame': '1 year', 'description': 'left ventricular ejection fraction evaluated by ultrasound'}, {'measure': 'Seattle Angina Questionnaire scores', 'timeFrame': '1 year', 'description': 'Seattle Angina Questionnaire scores'}, {'measure': '6-minute walk distance (6MWD)', 'timeFrame': '1 year', 'description': '6-minute walk distance (6MWD)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['ST-segment Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).', 'detailedDescription': 'This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-80;\n* Diagnosed as STEMI for presenting symptoms or definite ECG and myocardial markers changes;\n* Patients presenting with definite ECG changes indicating STEMI: ST elevation of 0.1 mV in 2 contiguous limb leads or ≥0.2 mV in 2 contiguous precordial leads;\n* Referred for PCI for presenting symptoms, and the coronary angiogram (CAG) shows that the initial TIMI thrombus grade ≥2;\n* Informed consent.\n\nExclusion Criteria:\n\n* Previous history of myocardiopathy, valvular heart disease or severe heart failure;\n* Severe hepatic or renal dysfunction;\n* Life expectancy less than 1 year;\n* Prior PCI or CABG;\n* Contraindications of using anticoagulation or antiplatelet drugs.'}, 'identificationModule': {'nctId': 'NCT02606435', 'briefTitle': 'Thrombus Aspiration in Patients With STEMI', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)', 'orgStudyIdInfo': {'id': 'SEED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'thrombus aspiration with PCI', 'description': 'patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI)', 'interventionNames': ['Procedure: percutaneous coronary intervention (PCI)', 'Device: thrombus aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCI alone', 'description': 'patients will receive percutaneous coronary intervention (PCI) alone including stent implantation', 'interventionNames': ['Procedure: percutaneous coronary intervention (PCI)']}], 'interventions': [{'name': 'percutaneous coronary intervention (PCI)', 'type': 'PROCEDURE', 'otherNames': ['primary percutaneous coronary intervention (PCI)'], 'description': 'percutaneous coronary intervention (PCI) by stent implantation', 'armGroupLabels': ['PCI alone', 'thrombus aspiration with PCI']}, {'name': 'thrombus aspiration', 'type': 'DEVICE', 'otherNames': ['export catheter'], 'description': 'thrombus aspiration with export catheter', 'armGroupLabels': ['thrombus aspiration with PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongdong Sun, M.D.,Ph.D', 'role': 'CONTACT', 'email': 'wintersun3@gmail.com', 'phone': '86 18691569930'}], 'facility': 'Xijing hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Dongdong Sun, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'wintersun3@gmail.com', 'phone': '86 29 84775183'}], 'overallOfficials': [{'name': 'Dongdong Sun, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Air Force Military Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'sunddong', 'investigatorAffiliation': 'Xijing Hospital'}}}}