Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-03-05 @ 6:09 PM
Study NCT ID:
NCT03444259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2018-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006338', 'term': 'Heart Neoplasms'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Atrial appendage, valves, ascending aorta, pericardium'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1001}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2018-02-15', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation', 'timeFrame': 'postoperatively until 5 years follow-up', 'description': 'Occurrence of atrial fibrillation'}], 'secondaryOutcomes': [{'measure': 'Stroke', 'timeFrame': 'postoperatively until 5 years follow-up', 'description': 'Occurrence of stroke'}, {'measure': 'Transient ischemic attack', 'timeFrame': 'postoperatively until 5 years follow-up', 'description': 'Occurrence of Transient ischemic attack'}, {'measure': 'Myocardial infarction', 'timeFrame': 'postoperatively until 5 years follow-up', 'description': 'Occurrence of Myocardial infarction'}, {'measure': 'Target vessel revascularization', 'timeFrame': 'postoperatively until 5 years follow-up', 'description': 'Occurrence of Target vessel revascularization'}, {'measure': 'All-cause Mortality', 'timeFrame': 'postoperatively until 5 years follow-up', 'description': 'All-cause Mortality'}, {'measure': 'Post-pericardiotomy syndrome', 'timeFrame': 'postoperatively until 1 years follow-up', 'description': 'Occurrence of Post-pericardiotomy syndrome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Aortic stenosis', 'Coronary artery disease', 'Cardiac surgery', 'Atrial appendage'], 'conditions': ['Atrial Fibrillation', 'Coronary Artery Disease', 'Aortic Valve Stenosis', 'Aortic Valve Disease', 'Mitral Valve Disease', 'Cardiac Arrythmias', 'Cardiac Tumor', 'Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '39091640', 'type': 'DERIVED', 'citation': 'Maaniitty E, Sinisilta S, Jalkanen J, Vasankari T, Biancari F, Gunn J, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi T. Distinct circulating cytokine levels in patients with angiography-proven coronary artery disease compared to disease-free controls. Int J Cardiol Cardiovasc Risk Prev. 2024 Jul 4;22:200307. doi: 10.1016/j.ijcrp.2024.200307. eCollection 2024 Sep.'}, {'pmid': '39068298', 'type': 'DERIVED', 'citation': 'Maaniitty E, Jalkanen J, Sinisilta S, Gunn J, Vasankari T, Biancari F, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi T. Differential circulating cytokine profiles in acute coronary syndrome versus stable coronary artery disease. Sci Rep. 2024 Jul 27;14(1):17269. doi: 10.1038/s41598-024-68333-7.'}, {'pmid': '34782683', 'type': 'DERIVED', 'citation': 'Viikinkoski E, Jalkanen J, Gunn J, Vasankari T, Lehto J, Valtonen M, Biancari F, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi TO. Red blood cell transfusion induces abnormal HIF-1alpha response to cytokine storm after adult cardiac surgery. Sci Rep. 2021 Nov 15;11(1):22230. doi: 10.1038/s41598-021-01695-4.'}]}, 'descriptionModule': {'briefSummary': 'The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures. Specifically, the investigators aim at comparing atrial phenotypes from atrial fibrillation patients and controls. The work consists of three broad categories: A) role of atrial cardiomyopathy in atrial fibrillation; B) genetic defects predisposing to atrial fibrillation; and C) the role of inflammation in atrial fibrillation.', 'detailedDescription': 'The investigators aim to A) compare atrial cardiomyopathy findings from the tissue samples to clinical phenotype and adverse events B) study the association of genetic defects predisposing to atrial fibrillation with atrial cardiomyopathy findings in the tissue samples C) assess the role of inflammation in atrial fibrillation by comparing circulating cytokine profiles, purinergic signaling and atrial cardiomyopathy findings in tissue samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing open-heart cardiac surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any open-heart cardiac surgery\n* Written informed consent\n* All-comers design\n\nExclusion Criteria:\n\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT03444259', 'acronym': 'CAREBANK', 'briefTitle': 'Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Cardiovascular Research Consortium - a Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients', 'orgStudyIdInfo': {'id': 'T273/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial fibrillation', 'description': 'Patients with atrial fibrillation', 'interventionNames': ['Procedure: Cardiac surgery']}, {'label': 'Coronary bypass', 'description': 'Patients undergoing coronary bypass', 'interventionNames': ['Procedure: Cardiac surgery']}, {'label': 'Aortic valve replacement', 'description': 'Patients undergoing aortic valve replacement', 'interventionNames': ['Procedure: Cardiac surgery']}, {'label': 'Mitral valve repair', 'description': 'Patients undergoing mitral valve repair', 'interventionNames': ['Procedure: Cardiac surgery']}, {'label': 'Other', 'description': 'Patients undergoing cardiac surgery for indication other than above', 'interventionNames': ['Procedure: Cardiac surgery']}], 'interventions': [{'name': 'Cardiac surgery', 'type': 'PROCEDURE', 'description': 'Open heart surgery', 'armGroupLabels': ['Aortic valve replacement', 'Atrial fibrillation', 'Coronary bypass', 'Mitral valve repair', 'Other']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Tuomas O Kiviniemi, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Turku University Hospital'}, {'name': 'Jarmo Gunn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist, MD, PhD, FESC', 'investigatorFullName': 'Tuomas Kiviniemi', 'investigatorAffiliation': 'University of Turku'}}}}