NCT03900390

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
Last Updated

April 3, 2019

Status Verified

March 1, 2019

Enrollment Period

5 years

First QC Date

March 4, 2019

Last Update Submit

March 30, 2019

Conditions

Ischemic Preconditioning

Keywords

heart transplantationischemia-reperfusion injury

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • inotrope score

    3days

  • serum creatinine level

    3days

  • ICU time

    up to 2 weeks

  • 6-minute walk test

    2weeks

Study Arms (2)

Cross Ischemic Preconditioning Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

cross-preconditioningPROCEDURE

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.

Cross Ischemic Preconditioning Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent heart transplantation；
  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of sun yat-sen university

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhongkai Wu

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Mengya Liang

CONTACT

13560172190infisdsums@163.com

Huayang Li

CONTACT

188194611861483409914@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 4, 2019

First Posted

April 3, 2019

Study Start

July 7, 2017

Primary Completion

July 7, 2022

Study Completion

July 7, 2023

Last Updated

April 3, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)