Myocardial Ischemic Reperfusion InjuryNCT02149316
Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery
A study testing RIPC+RIPostC in people with Myocardial Ischemic Reperfusion Injury and End Stage Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Myocardial Ischemic Reperfusion Injury, End Stage Heart Disease, Heart Failure
- What is being tested?
- RIPC+RIPostC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Feb 2016
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- scheduled for elective orthotopic heart transplantation surgery
Who cannot join
- peripheral vascular disease affecting the upper arms
- mechanical circulatory support before surgery
- taking the antidiabetic sulphonylurea, glibenclamide
- cold ischemic time of donor heart > 12 hours
- repeated heart surgery
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
Beijing, 100037
About this study
Official title: Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery
The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.
- Conditions
- Myocardial Ischemic Reperfusion Injury, End Stage Heart Disease, Heart Failure, Cardiomyopathy
- Being tested
- RIPC+RIPostC, control
- Medical subject headings
- Myocardial Reperfusion Injury, Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPC+RIPostCProcedure or surgery
Four 5 min cycles of upper limb ischemia and reperfusion by a cuff inflated to 200 mmHg, twice (after anesthesia induction and before surgery started, at 20min after aortic declamping)
controlProcedure or surgery
a deflated cuff placed on the right upper arm
| Study group | Role | What they receive |
|---|---|---|
| RIPC+RIPostC | Experimental | Not described Receives: Procedure: RIPC+RIPostC |
| control | Sham comparator | Not described Receives: Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum cardiac troponin I (cTnI)
Measured: within 72 hours after aortic declamping
Secondary outcomes (2)
plasma microRNA-133b (miR-133b)
Measured: within 72 hours after aortic declamping
plasma microRNA-208a (miR-208a)
Measured: within 72 hours after aortic declamping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Ischemic Reperfusion InjuryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Guyan Wang, PhD, Principal investigator, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149316
- Sponsor's protocol ID
- FW2012-863B-C
- Status last verified
- Dec 2016
- First submitted
- 26 May 2014
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery
- ClinicalTrials.gov ID
- NCT02149316
- Acronym / sponsor ID
- FW2012-863B-C
- Conditions
- Myocardial Ischemic Reperfusion Injury, End Stage Heart Disease, Heart Failure, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 May 2014 (estimated)
- 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.
The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC+RIPostC | Experimental | Procedure: RIPC+RIPostC |
| control | Sham comparator | Procedure: control |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for elective orthotopic heart transplantation surgery
Key exclusion criteria (5 listed)
- peripheral vascular disease affecting the upper arms
- mechanical circulatory support before surgery
- taking the antidiabetic sulphonylurea, glibenclamide
- cold ischemic time of donor heart > 12 hours
- repeated heart surgery
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 |
|---|---|---|
| RIPC+RIPostCFour 5 min cycles of upper limb ischemia and reperfusion by a cuff inflated to 200 mmHg, twice (after anesthesia induction and before surgery started, at 20min after aortic declamping) | Procedure or surgery | RIPC+RIPostC |
| controla deflated cuff placed on the right upper arm | Procedure or surgery | control |
Primary outcome
serum cardiac troponin I (cTnI)
Time frame: within 72 hours after aortic declamping
2 secondary outcomes
plasma microRNA-133b (miR-133b)
Time frame: within 72 hours after aortic declamping
plasma microRNA-208a (miR-208a)
Time frame: within 72 hours after aortic declamping
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
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.
Guyan Wang, PhD principal investigator
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC+RIPostC in people with Myocardial Ischemic Reperfusion Injury and End Stage Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 23 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum cardiac troponin I (cTnI) (time frame: within 72 hours after aortic declamping). 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 23 Dec 2016; AzTrials last refreshed its copy on 31 Oct 2026.