Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT05510661
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2021-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Export in Primary Percutaneous Coronary Intervention
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinded in-hospital outcomes assessment will be insured by separating patients recruitment and follow-up team and follow-up team will be kept blinded of randomization. All the patients will be assigned a unique identity code and collected data will be stored against the assigned code.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Manual thrombus aspiration (use of export catheter) followed by primary PCI'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2022-08-19', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post thrombus aspiration TIMI flow', 'timeFrame': 'Immediately after export/balloon', 'description': 'Immediate TIMI flow after export/balloon'}, {'measure': 'Slow/No-reflow', 'timeFrame': 'Immediately after procedure', 'description': 'TIMI 0-II flow'}, {'measure': 'Major adverse cardiac events', 'timeFrame': 'In-hospital, at 1 month, and at 6 months', 'description': 'It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['ST-segment Elevation Myocardial Infarction (STEMI)', 'Total Occlusion of Coronary Artery', 'Primary Percutaneous Coronary Intervention']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Kumar D, Saghir T, Sial JA, Kumar R, Karim M, Huma ZE, Qamar N. Use of export vs. balloon in primary percutaneous coronary intervention, in-hospital outcomes and optimal export time. Journal of the American College of Cardiology. 2021 May 11; 77(18_Supplement_1): 1034.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this single center randomized open label trial with blinded in-hospital outcomes assessment is designed with aim to compare manual thrombus aspiration followed by percutaneous coronary intervention (PCI) strategy with PCI alone.', 'detailedDescription': 'Clinical benefit of manual aspiration has been a contentious point of debate and it is Class III indication in current clinical practice guidelines, however, recent observational data by Kumar D et al. showed benefits of usage of export in terms of favorable in-hospital outcomes and lesser complication rate in patients with total occlusion, furthermore, benefits of usage of export was observed to be directly associated with duration of chest pain at the time of thrombus aspiration. However, these observations are limited to immediate and in-hospital outcomes and data regarding efficacy of manual thrombus aspiration are not available.\n\nHence this single center randomized open label trial is designed with specific aim to test the following hypothesis for STEMI patients with total occlusion undergoing primary PCI;\n\n* Whether use of export catheter reduces in-hospital and short term adverse events\n* Whether use of export reduces slow flow or no reflow\n* Whether use of export reduces the use of intracoronary drugs\n* Whether use of export within 6 hours of symptom onset significantly reduces in-hospital and short term adverse events\n\nConsecutively recruited patients will be randomized to either primary PCI with export or primary PCI alone group in 2:1 ratio. Post aspiration immediate TIMI flow will be observed and all the patients will be observed for adverse outcomes (MACE) and complications including slow flow/no-reflow. Follow-up intervals will be at the end of one month of randomization and end of 6 month of randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes\n* Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads\n* Chest pain \\< 12 hours duration\n* Total occlusion (TIMI 0 flow)\n* Patients undergoing primary PCI\n* Informed consent\n\nExclusion Criteria:\n\n* Patients with prior history of cardiac related surgery or intervention\n* Performance of a rescue PCI after thrombolysis\n* Known existence of a disease resulting in a life expectancy of less than 6 months\n* Killip class III, IV'}, 'identificationModule': {'nctId': 'NCT05510661', 'acronym': 'EPISOO', 'briefTitle': 'Use of Export in Primary Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Cardiovascular Diseases, Pakistan'}, 'officialTitle': 'Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export', 'orgStudyIdInfo': {'id': 'ERC-63/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Manual thrombus aspiration (use of export catheter) followed by primary PCI', 'interventionNames': ['Device: Export Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI', 'interventionNames': ['Device: Balloon catheter']}], 'interventions': [{'name': 'Export Catheter', 'type': 'DEVICE', 'otherNames': ['Thrombus Aspiration'], 'description': 'Manual thrombus aspiration with the use of export catheter during primary PCI', 'armGroupLabels': ['Intervention Group']}, {'name': 'Balloon catheter', 'type': 'DEVICE', 'description': 'Predilatation with balloon catheter', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75510', 'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Dr Faiza Farooq, FCPS', 'role': 'CONTACT', 'email': 'drffaziz@gmail.com', 'phone': '923002426460'}, {'name': 'Dr Tahir Saghir', 'role': 'CONTACT', 'email': 'tahirsaghir@gmail.com', 'phone': '+9299201271'}], 'facility': 'National Institute of Cardiovascular Diseases', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Dr Faiza Farooq, FCPS', 'role': 'CONTACT', 'email': 'drffaziz@gmail.com', 'phone': '+923002426460'}, {'name': 'Tahir Saghir, FCPS', 'role': 'CONTACT', 'email': 'tahirsaghir@gmail.com', 'phone': '+923002199844'}], 'overallOfficials': [{'name': 'Dr Fiaza Farooq, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiovascular Diseases, Pakistan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Acting Associate Professor', 'investigatorFullName': 'Faiza Farooq', 'investigatorAffiliation': 'National Institute of Cardiovascular Diseases, Pakistan'}}}}