- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Basse Normandie
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Caen, Basse Normandie, 프랑스, 14000
- 모병
- Joachim ALEXANDRE
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연락하다:
- Mathieu CHEQUEL, MD
- 전화번호: +33625342363
- 이메일: chequel-m@chu-caen.fr
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연락하다:
- Pierre OLLITRAULT, MD
- 전화번호: +33624922671
- 이메일: ollitrault-p@chu-caen.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
기간: 1 month
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1 month
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2차 결과 측정
결과 측정 |
기간 |
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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.
기간: 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.
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 1 month
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1 month
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
심방세동에 대한 임상 시험
-
Assistance Publique - Hôpitaux de Paris아직 모집하지 않음과도한 Supraventricular Ectopies 또는 Short Atrial Runs(ESVEA)
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University of Pennsylvania빼는전형적인 심방 조동 | Atrial Flutter의 향후 개발 위험 요소미국