- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02814903
ALDOsterone for Prediction of Post-Operative Atrial Fibrillation (ALDO-POAF)
Post-operative atrial fibrillation (POAF) is a major and frequent complication occurring after cardiac surgery, contributing to prolonged intensive care and hospital stays and is associated with several cardiovascular complications. The exact mechanisms and signaling pathways involved in the development of POAF seem to be multifactorial and remain to date incompletely understood. β-blockers and amiodarone are the first line preventive drugs but are partially effective and near 30% of POAF resist to these strategies. In this context, there is some evidence indicating that renin-angiotensin-aldosterone system and Galectin-3 (Gal-3) share signaling pathways in the development of cardiac fibrosis and therefore could be very useful predictive biomarkers of POAF and potentially interesting therapeutic target to prevent POAF occurrence.
The investigators hypothesis is that preoperative plasma aldosterone levels and galectin-3 (Gal-3) expression (in plasma, right atrial appendage or epicardial fat) could be predictive of POAF in patients undergoing elective CABG surgery with preserved LVEF.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Basse Normandie
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Caen, Basse Normandie, Frankrig, 14000
- Rekruttering
- Joachim ALEXANDRE
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Kontakt:
- Mathieu CHEQUEL, MD
- Telefonnummer: +33625342363
- E-mail: chequel-m@chu-caen.fr
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Kontakt:
- Pierre OLLITRAULT, MD
- Telefonnummer: +33624922671
- E-mail: ollitrault-p@chu-caen.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients hospitalized for planned surgical coronary revascularization +/- aortic replacement valve
- Aged 18 years at least
- Clinically Stable (see criteria for non-inclusion)
- With left ventricular ejection fraction preserved (>50%)
Exclusion Criteria:
- Patient having already AF history
- Patient with primary hyperaldosteronism
- Unstable Patient defined as any cardiovascular event occurred in the previous 30 days
These events are:
- hospitalisation for cardiovascular causes
- appearance or worsening of symptoms consistent with cardiac failure
- appearance or worsening symptoms of coronary
- Patient refusing participation in the study
- Patient unable to provide follow-up visits
- need for concomitant mitral surgery
- Emergency CABG
- Left ventricular ejection fraction (LVEF) < 50%
- Previous heart surgery
- Off pump CABG.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Planned cardiac surgery. POAF occurence or not
The ALDO-POAF study is an observational, 1-center and prospective pilot study that will enroll patients undergoing CABG ± aortic valve replacement.
Patients who had emergency CABG, need for concomitant mitral surgery, left ventricular ejection fraction (LVEF) < 50%, a history of AF or other atrial arrhythmia, unstable angina or heart failure, cardiogenic shock, atrioventricular block, hypothyroidism/hyperthyroidism, previous heart surgery, and off-pump or on-pump beating CABG will be excluded.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
Tidsramme: 1 month
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1 month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Find a correlation between the local secretion of aldosterone by adipocytes epicardial and the occurrence of AF during the 6 months after surgery in patients undergoing cold bypass coronary artery.
Tidsramme: 6 months
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6 months
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Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels.
Tidsramme: 1 month
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1 month
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Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation
Tidsramme: 1 month
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1 month
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Detect aldosterone synthase aldosterone or angiotensin II (measured by quantitative and qualitative assays Western Blot, mRNA or RT-PCR) in the epicardial fat removed during surgery in patients undergoing a CABG.
Tidsramme: 1 month
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1 month
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Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation
Tidsramme: 1 month
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1 month
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Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation
Tidsramme: 1 month
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1 month
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Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation
Tidsramme: 1 month
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1 month
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Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation
Tidsramme: 1 month
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1 month
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Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation
Tidsramme: 1 month
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1 month
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Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality
Tidsramme: 2 years
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2 years
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Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation
Tidsramme: 1 month
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1 month
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A14-D05-VOL.20
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Henry Ford Health SystemTrukket tilbage
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
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HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
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Occlutech International ABAfsluttetSecundum atrial septal defekter
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Institute of Cardiology, Warsaw, PolandUkendtOstium Secundum AtrieseptumdefektPolen