Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-07 @ 5:41 AM
Study NCT ID:
NCT04309994
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2020-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myocardial damage', 'timeFrame': 'patients with that received a coronary artery bypass grafting and that were treated (for approximately 15 days) at the University Hospital between February 2010 and January 2020 (data taken perioperative during hospital stay for CABG)', 'description': 'Analyse cardiac biomarkers as indicators for myocardial damage: high sensitive troponin (Ths-TrT, ng/mL), creatine kinase (CK, in ng/mL) and creatine kinase-MB isoenzyme (CK-MB, in ng/mL)'}], 'secondaryOutcomes': [{'measure': '30 days Mortality', 'timeFrame': '30 days after CABG', 'description': 'death after coronary artery bypass grafting'}, {'measure': 'length of stay in the intensive care unit', 'timeFrame': 'perioperative during hospital stay for CABG (for approximately 15 days)', 'description': 'duration of stay at intensive care unit'}, {'measure': 'Number of participants with bleedings', 'timeFrame': 'perioperative during hospital stay for CABG (for approximately 15 days)', 'description': 'bleeding complication after coronary artery bypass grafting'}, {'measure': 'Number of participants with postoperative arrhythmia', 'timeFrame': 'perioperative during hospital stay for CABG (for approximately 15 days)', 'description': 'rhythm disturbance after coronary artery bypass grafting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart attack', 'cardioplegia solution', 'Minimal extracorporeal circulation system (MiECC)', 'Myocardial protection system (MPS)', 'Coronary artery bypass grafting (CABG)'], 'conditions': ['Heart Attack', 'Cardioplegia Solution Adverse Reaction', 'Coronary Artery Bypass Grafting (CABG)']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the two cardioplegia solutions (blood cardioplegia by means of MPS ® vs. Cardioplexol ®) regarding perioperative outcome and with special attention to cardiac markers in patients with a recent heart attack.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients which underwent isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent a CABG using MPS® or Cardioplexol ®\n* Heart attack less than 7 days before surgery\n\nExclusion Criteria:\n\n* use of other cardioplegia solution than Cardioplexol ® or MPS®\n* other inventions than CABG\n* explicit will of the patient that his data may not be used\n* denied general consent'}, 'identificationModule': {'nctId': 'NCT04309994', 'briefTitle': 'Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '2019-02383; ch20Reuthebuch'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'bypass surgery with blood cardioplegia by means of MPS', 'interventionNames': ['Other: Myocardial protection system (MPS)']}, {'label': 'Active Comparator', 'description': 'bypass surgery with blood cardioplegia by means of Cardioplexol ®', 'interventionNames': ['Other: Cardioplexol']}], 'interventions': [{'name': 'Myocardial protection system (MPS)', 'type': 'OTHER', 'description': 'cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used', 'armGroupLabels': ['Experimental']}, {'name': 'Cardioplexol', 'type': 'OTHER', 'description': 'cardioplegia solution', 'armGroupLabels': ['Active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Cardiac Surgery Clinic University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Oliver Reuthebuch, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiac Surgery Clinic, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}