Transfer of Cardioprotection During RIPC
Transfer of Cardioprotection During Remote Ischemic Conditioning
Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective CABG surgery.
The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify the pathways which transfer the cardioprotective signal from the ischemic/reperfused extremity to the heart in humans undergoing surgical coronary revascularization.
연구 개요
상세 설명
The investigators will obtain arterial blood samples before skin incision and 1-72 h after the remote ischemic preconditioning protocol and analyze them biochemically. The investigators focus on those ligands that have been previously implicated in conditioning protocols at any organ. In addition, the investigators will use a bioassay system, consisting of a Langendorff-perfused isolated heart with coronary occlusion/reperfusion and infarct size by TTC staining as endpoint, and then expose this bioassay system to arterial plasma obtained after the remote ischemic preconditioning stimulus or placebo. This approach will allow us to further characterize any potential transfer signal candidate with a pharmacological antagonist approach.
The investigators will also obtain human atrial appendages after the remote ischemic preconditioning protocol or placebo and before patients were connected to the extracorporeal circulation. Contractile function of isolated trabeculae and vasomotor function of isolated arterial vessels will be analyzed in a bioassay system.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Essen, 독일, 4130
- Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Consecutive patients > 18 years after written informed consent
- elective, isolated CABG surgery with and without valvuloplastic surgery
- two-stage cannulation, cardiopulmonary bypass
- antegrade Bretschneider cardioplegia
- mild hypothermia (32°C)
- preoperative standard medication (statins, betablocker, aspirin)
- standard anesthesia (see above)
- intraoperative standard protocol (full heparinization with ACT, aprotinin, protamin)
- postoperative standard protocol (500 mg aspirin after 2 h, low-dose heparin after 4 h)
Exclusion Criteria:
preoperative
- prior percutaneous coronary intervention (PCI) within 6 weeks
- any preoperative troponin T elevation
- renal insufficiency (creatinine >200 µmol/l)
- reoperation
- emergency surgery
- acute coronary syndrome (unstable angina, STEMI, NSTEMI) within 4 weeks
- dual anti-platelet therapy (clopidogrel+aspirin)
intraoperative
- harvesting of a. radialis
- coronary thrombendarterectomy
- complications (bypass-low flow/ -occlusion)
- antithrombotic therapy (intraoperative clopidogrel + aspirin)
- retrograde cardioplegia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Remote ischemic preconditioning
Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG): after induction of anesthesia and before surgery: 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200mmHg and 5 minutes of reperfusion Anesthesia is with isoflurane (0.7-0.8% end-tidal) +sufentanil |
혈압 커프를 200 mmHg로 팽창시키고 5분 재관류하여 5분 왼쪽 상완 허혈의 3주기
다른 이름들:
|
|
위약 비교기: Placebo
No Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG): after induction of anesthesia and before surgery: the cuff is left uninflated |
혈압 커프를 200 mmHg로 팽창시키고 5분 재관류하여 5분 왼쪽 상완 허혈의 3주기
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Myocardial protection
기간: 72 h, postoperatively
|
Cumulative postoperative troponin T release
|
72 h, postoperatively
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
All-cause mortality
기간: 30 days and 1 year after CABG surgery and after complete follow-up
|
follow up done by studynurses
|
30 days and 1 year after CABG surgery and after complete follow-up
|
|
MACCE
기간: 30 days and 1 year after CABG surgery after complete follow-up
|
Major adverse cardiac and cerebrovascular events
|
30 days and 1 year after CABG surgery after complete follow-up
|
|
renal function
기간: 72 h, postoperatively
|
Creatinine and eGFR
|
72 h, postoperatively
|
|
Cardioprotective factors released into circulating blood
기간: before skin incision versus 1-72 h after RIPC
|
Analysis of blood plasma
|
before skin incision versus 1-72 h after RIPC
|
|
Myocardial function in vitro
기간: after RIPC
|
left ventricular pressure (lvp) and maximum left ventricular pressure (lvdp) in an isolated perfused rodent heart after blood plasma infusion
|
after RIPC
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Markus Kamler, MD, Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen, Essen, Germany
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RIPC-13-5507-BO
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. .