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

Ischemic Preconditioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03900390
• Other study ID #: FirstSunYetSen118
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2017
• Est. completion date: July 7, 2023

Study information

• Verified date: March 2019
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Mengya Liang
• Phone: 13560172190
• Email: infisdsums[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Preconditioning
• Reperfusion Injury

Intervention

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.

Locations

Country	Name	City	State
China	The first affiliated hospital of sun yat-sen university	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Mengya Liang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	inotrope score	calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery	3days
Secondary	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
Secondary	ICU time	duration of stay in the intensive care unit and hospital	up to 2 weeks
Secondary	6-minute walk test	distance on the 6-minute walk test two weeks after surgery	2weeks