Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 9:20 AM
Study NCT ID:
NCT00970034
Status:
UNKNOWN
Last Update Posted:
2009-09-03
First Post:
2009-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression Profiles in Patients With Permanent Atrial Fibrillation (AF) Versus Sinus Rhythm (SR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Human atrial tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-02', 'studyFirstSubmitDate': '2009-09-01', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression profiles of genes related to apoptosis', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Expression profiles of pro-apoptotic and anti-apoptotic proteins', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation, apoptosis, oligonucleotide microarray'], 'conditions': ['Mitral Regurgitation', 'Atrial Fibrillation', 'Sinus Rhythm']}, 'referencesModule': {'references': [{'pmid': '34737791', 'type': 'DERIVED', 'citation': 'Cubukcuoglu Deniz G, Durdu S, Dogan Y, Erdemli E, Ozdag H, Akar AR. Molecular Signatures of Human Chronic Atrial Fibrillation in Primary Mitral Regurgitation. Cardiovasc Ther. 2021 Oct 15;2021:5516185. doi: 10.1155/2021/5516185. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to determine the morphological criteria of apoptosis in atrial tissues of patients with AF versus SR at transcriptome and genomic size.', 'detailedDescription': 'Mitral valve regurgitation (MR) is the second most common valvular heart disease encountered in adults. Furthermore, atrial fibrillation (AF) is the most common cardiac arrhythmia seen in clinical practice. Overall, 70% of the patients with severe MR are associated with AF independent from etiopathogenesis of MR. AF is clinically divided into three subgroups; 1) paroxysmal AF, occurs as episodes and ends spontaneously, 2) persistent AF, episodes terminate only with medical or electrical cardioversion, and 3) permanent AF, current medical treatments and electrical cardioversion does not restore a normal sinus rhythm. Despite intensive electrophysiological studies, the molecular mechanisms and pathways of AF are still not fully elucidated.\n\nApoptosis which has distinctive morphological and biochemical characteristics is genetically regulated, active programmed cell death process. It is known that cardiac morphogenesis restore from apoptosis. In addition, apoptosis has an important role in several cardiovascular system pathologies. It has been shown that atrial apoptosis causes numerous arrhythmias including AF. Likewise, in the pilot study which has been performed by our study group, AF is associated with apoptosis by immunohistochemical and DNA fragmentation analysis methods.\n\nThe aim of this project is to determine the morphological criteria of apoptosis in atrial tissues of patients with AF by using electron microscopy and immunohistochemistry. Moreover, we will investigate the transcriptional profile of AF associated genes by oligonucleotide microarray method. The gene expression profiles of patients with AF and degenerative MR will be compared with the atrial tissue samples from the patients with degenerative MR who preserve normal sinus rhythm which will serve as controls. In summary the apoptotic pathways would be analyzed at transcriptomic and genomic level. Besides, the pathways that may interfere AF pathophysiology would also be evaluated. The expression profiles of the genes primarily verified by quantitative real time RT-PCR will be further confirmed by translation of end-result proteins determined with Western blot technique. Thus, brand-new clues about physiology of fibrillating atrial cells would be achieved.\n\nKeywords: Atrial fibrillation, apoptosis, oligonucleotide microarray'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Degenerative mitral valve regurgitation who require cardiac valve surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with permanent atrial fibrillation or sinus rhythm and degenerative mitral valve regurgitation who require cardiac surgery\n* Pulmonary hypertension (systolic PA \\> 45 mmHg)\n* Left ventricular ejection fraction \\> 30%\n\nExclusion Criteria:\n\n* Paroxysmal AF or atrial flutter\n* Second or third degree heart block\n* Permanent pacemaker\n* Wolff-Parkinson-White syndrome\n* Brugada syndrome\n* Ischemic or rheumatic mitral valve disease\n* Dilated cardiomyopathy\n* LVEF \\< 30%\n* Infective endocarditis, myocarditis\n* Trauma\n* Active HBV, HCV, HIV infection\n* Chronic renal failure\n* Autoimmune diseases\n* Vasculitis\n* Known genetic disorders'}, 'identificationModule': {'nctId': 'NCT00970034', 'briefTitle': 'Gene Expression Profiles in Patients With Permanent Atrial Fibrillation (AF) Versus Sinus Rhythm (SR)', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Comparative Gene Expression Profiles in Patients With Permanent Atrial Fibrillation and Normal Sinus Rhythm', 'orgStudyIdInfo': {'id': '108S375'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AF', 'description': 'Patients with degenerative mitral valve regurgitation and permanent atrial fibrillation who require mitral valve repair or replacement.'}, {'label': 'SR', 'description': 'Patients with degenerative mitral valve regurgitation and maintaining sinus rhythm who require mitral valve repair or replacement.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06340', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'GUNSELI CUBUKCUOGLU', 'role': 'CONTACT', 'email': 'gunselicubukcu@gmail.com', 'phone': '+905336424994'}, {'name': 'SERKAN DURDU', 'role': 'CONTACT', 'email': 'serkandurdu@gmail.com', 'phone': '+905336373535'}, {'name': 'RUCHAN A AKAR, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'HILAL OZDAG, Assoc. Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'ARZU ATALAY, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'NALAN AKYUREK, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'HAKAN GURDAL, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'OMER AKYUREK, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'UMIT OZYURDA, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'GUNSELI CUBUKCUOGLU, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'SERKAN DURDU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'CAGIN ZAIM, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ankara University Medical Faculty, Department of Cardiovascular Surgery,', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'RUCHAN AKAR, Assoc. Prof.', 'role': 'CONTACT', 'email': 'akarruchan@gmail.com', 'phone': '+905336460684'}, {'name': 'HILAL OZDAG, Assoc. Prof.', 'role': 'CONTACT', 'email': 'hilalozdag@gmail.com', 'phone': '+905333717401'}], 'overallOfficials': [{'name': 'RUCHAN A AKAR, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'A. Ruchan Akar, Assoc. Prof.', 'oldOrganization': 'Ankara University'}}}}