ALDOsterone for Prediction of Post-Operative Atrial Fibrillation (ALDO-POAF)
27 juni 2016 uppdaterad av: University Hospital, Caen
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.
Studieöversikt
Status
Okänd
Betingelser
Studietyp
Observationell
Inskrivning (Förväntat)
500
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Basse Normandie
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Caen, Basse Normandie, Frankrike, 14000
- Rekrytering
- Joachim ALEXANDRE
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Kontakt:
- Mathieu CHEQUEL, MD
- Telefonnummer: +33625342363
- E-post: chequel-m@chu-caen.fr
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Kontakt:
- Pierre OLLITRAULT, MD
- Telefonnummer: +33624922671
- E-post: ollitrault-p@chu-caen.fr
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Approval for this study, including collection of human tissues (right atrial appendage, subcutaneous and epicardial fat) and blood collection, was obtained from the Ethics Committee of Caen University Hospital (Comité de Protection des Personnes Nord-Ouest III, Caen, France) and will be in accordance to the declaration of Helsinki; the details of the study will be explained to the subjects, and written informed consent will be obtained from each patient.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
Tidsram: 1 month
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1 month
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 month
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1 month
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Sponsor
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2014
Primärt slutförande (Förväntat)
1 juni 2017
Avslutad studie (Förväntat)
1 augusti 2017
Studieregistreringsdatum
Först inskickad
14 juni 2016
Först inskickad som uppfyllde QC-kriterierna
27 juni 2016
Första postat (Uppskatta)
28 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
28 juni 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juni 2016
Senast verifierad
1 juni 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A14-D05-VOL.20
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
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