The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- serum troponin T/ creatine kinase-MB level
研究概览
简要总结
In recent years, a large number of studies confirmed the protective effect of ischemic preconditioning on myocardium against ischemia/reperfusion injury, but the clinical data of the effectiveness of ischemic preconditioning in heart transplantation is still missing. Inspired by the promising data of ischemic preconditioning from the previous reports, the investigators firstly introduce a novel method of cross ischemic preconditioning technique to prevent ischemia/reperfusion injury to heart transplant recipients.
This study will evaluate whether this cross-preconditioning technique would attenuate ischemia/ reperfusion injury to the heart transplant recipients, reduce Intensive Care Unit(ICU) and total hospitalization stays and the incidence of cardiovascular adverse events and improve the long-term survival outcomes.
详细描述
Patients receiving heart transplantation are randomly assigned into the cross ischemic preconditioning (CICP) intervention group and the control group. (the Statistical Analysis System (SAS) software was used to generate a random number table and randomly divided into two groups). After the establishment of the cardiopulmonary bypass, the ascending aorta of the CICP group will be crossclamped 2 minutes, separated by a 3-minute rest interval, and repeated successively on 2 occasions.
The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent heart transplantation；
- •Signed informed consent.
排除标准
- •Systemic active infection;
- •Refractory respiratory failure or renal failure;
- •Severe systemic diseases with limited survival time.
- •ABO blood groups incompatibility
- •positive serum HIV antibody;
- •drug or alcohol abusing;
- •Mentally ill;
- •Recent history of severe pulmonary embolism
- •Have not signed informed consent.
研究组 & 干预措施
Cross Ischemic Preconditioning Group
the ascending aorta of the CIP group will be crossclamped to cease the blood supply for 2 minutes, separated by a 3-minute rest interval, and repeated successively on 2 occasions
干预措施: cross-preconditioning (Procedure)
Control Group
The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation without Ischemic Preconditioning manoeuvre.
结局指标
主要结局
serum troponin T/ creatine kinase-MB level
时间窗: 3days
troponin T/ creatine kinase-MB at definitive time points ( baseline, crossclamping, reperfusion, 6,24,48 and 72 hours postoperatively)
Number of Participants with major adverse cardiacand cerebrovascular events (MACCE) in one year postoperatively
时间窗: 1year
MACCE include death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or strok
次要结局
- 6-minute walk test(2weeks)
- ICU time(up to 2 weeks)
- inotrope score(3days)
- serum creatinine level(3days)
研究者
Mengya Liang
associate professor
First Affiliated Hospital, Sun Yat-Sen University