The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Preconditioning
• Intervention / Treatment: Procedure: cross-preconditioning

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengya Liang; Phone Number: 13560172190; Email: infisdsums@163.com
• Study Contact Backup: Name: Huayang Li; Phone Number: 18819461186; Email: 1483409914@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: Zhongkai Wu; Phone Number: 13602897178; Email: wuzhk@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who underwent heart transplantation；
2. Signed informed consent.

Exclusion Criteria:

1. Systemic active infection;
2. Refractory respiratory failure or renal failure;
3. Severe systemic diseases with limited survival time.
4. ABO blood groups incompatibility
5. positive serum HIV antibody;
6. drug or alcohol abusing;
7. Mentally ill;
8. Recent history of severe pulmonary embolism
9. Have not signed informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Procedure: cross-preconditioning; 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.
NO_INTERVENTION: Control Group; The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation without Ischemic Preconditioning manoeuvre.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum troponin T/ creatine kinase-MB level	troponin T/ creatine kinase-MB at definitive time points ( baseline, crossclamping, reperfusion, 6,24,48 and 72 hours postoperatively)	3days
Number of Participants with major adverse cardiacand cerebrovascular events (MACCE) in one year postoperatively	MACCE include death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or strok	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inotrope score	calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery	3days
serum creatinine level	grade 1, 2, or 3 acute kidney injury within 72 hours after surgery (assessed on the basis of the increase in the serum creatinine level according to the International Kidney Disease: Improving Global Outcomes classification	3days
ICU time	duration of stay in the intensive care unit and hospital	up to 2 weeks
6-minute walk test	distance on the 6-minute walk test two weeks after surgery	2weeks

Collaborators and Investigators

• Sponsor: Mengya Liang
• Investigators: Study Director: Zhongkai Wu, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2017
• Primary Completion (ANTICIPATED): July 7, 2022
• Study Completion (ANTICIPATED): July 7, 2023

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 30, 2019
• First Posted (ACTUAL): April 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: March 30, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: heart transplantation; ischemia-reperfusion injury
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Reperfusion Injury
• Other Study ID Numbers: FirstSunYetSen118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No