Ischemic PreconditioningNCT03900390
The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient
A study testing cross-preconditioning in people with Ischemic Preconditioning, run by Mengya Liang at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Preconditioning
- What is being tested?
- cross-preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2017to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who underwent heart transplantation；
- Signed informed consent.
Who cannot join
- 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;
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- Mentally ill;
- Recent history of severe pulmonary embolism
- Have not signed informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of sun yat-sen university
Guangzhou, Guangdong, 510000
Zhongkai Wu, 13602897178, wuzhk@mail.sysu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Ischemic Preconditioning
- Being tested
- cross-preconditioning
- Keywords
- heart transplantation, ischemia-reperfusion injury
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-preconditioningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1year
Secondary outcomes (4)
inotrope score
calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery
Measured: 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
Measured: 3days
ICU time
duration of stay in the intensive care unit and hospital
Measured: up to 2 weeks
6-minute walk test
distance on the 6-minute walk test two weeks after surgery
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start7 Jul 2017
- Primary completion7 Jul 2022 (estimated)
- Study completion7 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic PreconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mengya Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mengya Liang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhongkai Wu, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900390
- Sponsor's protocol ID
- FirstSunYetSen118
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient
- ClinicalTrials.gov ID
- NCT03900390
- Acronym / sponsor ID
- FirstSunYetSen118
- Conditions
- Ischemic Preconditioning
- Keywords
- heart transplantation, ischemia-reperfusion injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mengya LiangUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 7 Jul 2022 (estimated)
- Study completion
- 7 Jul 2023 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross Ischemic Preconditioning Group | Experimental | Procedure: cross-preconditioningthe 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 |
| Control Group | No intervention | –The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation without Ischemic Preconditioning manoeuvre. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent heart transplantation；
- Signed informed consent.
Key exclusion criteria (9 listed)
- Systemic active infection;
- Refractory respiratory failure or renal failure;
- Severe systemic diseases with limited survival time.
- ABO blood groups incompatibility
- positive serum HIV antibody;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cross-preconditioningAfter 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. | Procedure or surgery | Cross Ischemic Preconditioning Group |
Primary outcome
serum troponin T/ creatine kinase-MB level
Time frame: 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
Time frame: 1year
MACCE include death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or strok
4 secondary outcomes
inotrope score
Time frame: 3days
serum creatinine level
Time frame: 3days
ICU time
Time frame: up to 2 weeks
6-minute walk test
Time frame: 2weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: No
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Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
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Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongkai Wu study director
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cross-preconditioning in people with Ischemic Preconditioning, run by Mengya Liang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mengya Liang (13560172190, infisdsums@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum troponin T/ creatine kinase-MB level (time frame: 3days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.