- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00970034
Gene Expression Profiles in Patients With Permanent Atrial Fibrillation (AF) Versus Sinus Rhythm (SR)
Comparative Gene Expression Profiles in Patients With Permanent Atrial Fibrillation and Normal Sinus Rhythm
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Apoptosis 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.
The 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.
Keywords: Atrial fibrillation, apoptosis, oligonucleotide microarray
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Ankara, Tacchino, 06340
- Reclutamento
- Ankara University Medical Faculty, Department of Cardiovascular Surgery,
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Contatto:
- SERKAN DURDU
- Numero di telefono: +905336373535
- Email: serkandurdu@gmail.com
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Sub-investigatore:
- HILAL OZDAG, Assoc. Prof.
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Sub-investigatore:
- UMIT OZYURDA, Prof.
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Sub-investigatore:
- HAKAN GURDAL, Prof.
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Contatto:
- GUNSELI CUBUKCUOGLU
- Numero di telefono: +905336424994
- Email: gunselicubukcu@gmail.com
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Investigatore principale:
- RUCHAN A AKAR, Assoc. Prof.
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Sub-investigatore:
- ARZU ATALAY, PhD
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Sub-investigatore:
- NALAN AKYUREK, PhD
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Sub-investigatore:
- OMER AKYUREK, Prof.
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Sub-investigatore:
- GUNSELI CUBUKCUOGLU, MSc
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Sub-investigatore:
- CAGIN ZAIM, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients with permanent atrial fibrillation or sinus rhythm and degenerative mitral valve regurgitation who require cardiac surgery
- Pulmonary hypertension (systolic PA > 45 mmHg)
- Left ventricular ejection fraction > 30%
Exclusion Criteria:
- Paroxysmal AF or atrial flutter
- Second or third degree heart block
- Permanent pacemaker
- Wolff-Parkinson-White syndrome
- Brugada syndrome
- Ischemic or rheumatic mitral valve disease
- Dilated cardiomyopathy
- LVEF < 30%
- Infective endocarditis, myocarditis
- Trauma
- Active HBV, HCV, HIV infection
- Chronic renal failure
- Autoimmune diseases
- Vasculitis
- Known genetic disorders
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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AF
Patients with degenerative mitral valve regurgitation and permanent atrial fibrillation who require mitral valve repair or replacement.
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SR
Patients with degenerative mitral valve regurgitation and maintaining sinus rhythm who require mitral valve repair or replacement.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Expression profiles of genes related to apoptosis
Lasso di tempo: 6 months
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6 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Expression profiles of pro-apoptotic and anti-apoptotic proteins
Lasso di tempo: 6 months
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6 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: RUCHAN A AKAR, Assoc. Prof., Ankara University
Pubblicazioni e link utili
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Studia le date principali
Inizio studio
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 108S375
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .