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

Primary Purpose

Ischemic Preconditioning

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cross-preconditioning
Sponsored by
Mengya Liang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Preconditioning focused on measuring heart transplantation, ischemia-reperfusion injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The first affiliated hospital of sun yat-sen universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cross Ischemic Preconditioning Group

Control Group

Arm Description

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

The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation without Ischemic Preconditioning manoeuvre.

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

inotrope score
calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery
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
ICU time
duration of stay in the intensive care unit and hospital
6-minute walk test
distance on the 6-minute walk test two weeks after surgery

Full Information

First Posted
March 4, 2019
Last Updated
March 30, 2019
Sponsor
Mengya Liang
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1. Study Identification

Unique Protocol Identification Number
NCT03900390
Brief Title
The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient
Official Title
The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
July 7, 2022 (Anticipated)
Study Completion Date
July 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mengya Liang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Preconditioning
Keywords
heart transplantation, ischemia-reperfusion injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cross Ischemic Preconditioning Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation without Ischemic Preconditioning manoeuvre.
Intervention Type
Procedure
Intervention Name(s)
cross-preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
serum troponin T/ creatine kinase-MB level
Description
troponin T/ creatine kinase-MB at definitive time points ( baseline, crossclamping, reperfusion, 6,24,48 and 72 hours postoperatively)
Time Frame
3days
Title
Number of Participants with major adverse cardiacand cerebrovascular events (MACCE) in one year postoperatively
Description
MACCE include death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or strok
Time Frame
1year
Secondary Outcome Measure Information:
Title
inotrope score
Description
calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery
Time Frame
3days
Title
serum creatinine level
Description
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
Time Frame
3days
Title
ICU time
Description
duration of stay in the intensive care unit and hospital
Time Frame
up to 2 weeks
Title
6-minute walk test
Description
distance on the 6-minute walk test two weeks after surgery
Time Frame
2weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who underwent heart transplantation; Signed informed consent. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mengya Liang
Phone
13560172190
Email
infisdsums@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huayang Li
Phone
18819461186
Email
1483409914@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongkai Wu
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
The first affiliated hospital of sun yat-sen university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongkai Wu
Phone
13602897178
Email
wuzhk@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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