Ischemia-reperfusion(I/R)NCT02430116
Mitochondrial Apoptotic Pathway Induced by Myocardial Ischemia-Reperfusion Injury in Human
A study testing Ischemic postconditioning in people with Ischemia-reperfusion(I/R) and Cardiopulmonarybypass, run by WANG Yan-bin at 1 site in China.
Trial summary
Background: The cardiomyocytes apoptosis induced by ischemia-reperfusion(I/R) is one of the most important factors in the myocardial I/R injury(MIRI) undergoing cardiac valve replacement with cardiopulmonary bypass(CVRCPB),and Ischemic postconditioning (I-postC) can inhibit apoptosis of myocardial cells. Read more about this study
- Who is it for?
- Ages 21 to 59 years
- Conditions the study is for
- Ischemia-reperfusion(I/R), Cardiopulmonarybypass, the Mitochondrial Pathway
- What is being tested?
- Ischemic postconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to May 2015
- 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 21 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- New York Heart Association class II or III
- aged 21-59 years
- scheduled for first cardiac valve replacement with CPB
Who cannot join
- The patient with a history of heart operation or diabetes,
- with a history of liver and/or kidney dysfunction,
- with a history of coronary heart disease and the left ventricular ejection fraction(LVEF)<0.4, receiving drugs with pretreatment effectssuchas hormones, ATP-sensitive potassium (KATP) channel openers,insulin,et al. within preoperative one week,
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen SUN Yat-Sen Cardiovascular hospital
Shenzhen
Yanbin Wang, Master of Medicine, +8615816886696, wangyb666@126.com
About this study
Background: The cardiomyocytes apoptosis induced by ischemia-reperfusion(I/R) is one of the most important factors in the myocardial I/R injury(MIRI) undergoing cardiac valve replacement with cardiopulmonary bypass(CVRCPB),and Ischemic postconditioning (I-postC) can inhibit apoptosis of myocardial cells. Consequently, this study investigated the key genes and apoptosis signaling pathways of myocardium in patients undergoing CVRCPB.
Methods: A total of 36 New York Heart Association class II or III patients with rheumatic heart disease (RHD) of both sexes, aged 21-59 years, who were scheduled for first cardiac valve replacement with CPB in the investigators' hospital from February 2014 to May 2015, were randomly divided into the following three groups (n=12 each): negative control group (NEG group); I/R group (POS group); and I-postC group (Treat group). In the Treat group, the procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and cross-clamping for 30 s for three cycles, after which the ascending aorta was completely opened. The NEG and Treat groups were not treated. Thirty-six patients were assessed for arrhythmia and recovery of myocardial contractile function after reperfusion by electrocardiograms and degree of dependence on vasoactive drugs. The myocardial tissues of the right atrial appendage were obtained at 3 min before CPB was established in the NEG group, and at 45 min after opening the aorta in the POS and Treat groups. In all three groups, the myocardial tissues of the right atrial appendage were obtained and preserved at -80°C for further experiments. The right atrial appendage of three patients randomly selected in each group was fixed with RNA later (Qiagen, Hilden, Germany) in a centrifuge tube overnight at 4°C, and then preserved at -20°C for RNA extraction. Human 12×135K Gene Array profiling of mRNA expressions was undertaken in human cardiac muscle cells. Differentially expressed mRNAs verified by quantitative real-time RT-PCR were subjected to pathway analysis. The mRNA expressions of AIF, APAF1, CYCS, Bax, caspase-3, caspase-9, caspase-6, caspase-7, BCL2, BAG1, and PI3K were assessed by real-time RT-PCR and western blot analysis. The levels of myocardial apoptosis induced by I/R were investigated by TUNEL assays. The changes in MIRI induced by myocardial apoptosis were investigated by pathologic examination of the myocardium.
- Conditions
- Ischemia-reperfusion(I/R), Cardiopulmonarybypass, the Mitochondrial Pathway, Ischemic Postconditioning
- Being tested
- Ischemic postconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic postconditioningProcedure or surgery
Also called The intervention is neither a drug nor a device. It is a procedure.
In the Treat group, the procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and cross-clamping for 30 s for three cycles, after which the ascending aorta was completely opened.
| Study group | Role | What they receive |
|---|---|---|
| negative control group | No intervention | The myocardial tissues of the right atrial appendage were obtained at 3 min before CPB was established in the NEG group. |
| I/R group | Active comparator | The myocardial tissues of the right atrial appendage were obtained at 45 min after opening the aorta in the I/R group. Receives: Procedure: Ischemic postconditioning |
| I-postC group | Experimental | The procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and cross-clamping for 30 s for three cycles, after which the ascending aorta was completely opened. Receives: Procedure: Ischemic postconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery of myocardial contractile function after reperfusion
Measured: 1 day
degree of dependence on vasoactive drugs
Measured: 1 day
number of participants with postoperative arrhythmia
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-reperfusion(I/R)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WANG Yan-bin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, WANG Yan-bin, Shenzhen Sun Yat-sen Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430116
- Sponsor's protocol ID
- wangyanbin123
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Apoptotic Pathway Induced by Myocardial Ischemia-Reperfusion Injury in Human
- ClinicalTrials.gov ID
- NCT02430116
- Acronym / sponsor ID
- wangyanbin123
- Conditions
- Ischemia-reperfusion(I/R), Cardiopulmonarybypass, the Mitochondrial Pathway, Ischemic Postconditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- WANG Yan-binUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 30 Apr 2015 (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.
Background: The cardiomyocytes apoptosis induced by ischemia-reperfusion(I/R) is one of the most important factors in the myocardial I/R injury(MIRI) undergoing cardiac valve replacement with cardiopulmonary bypass(CVRCPB),and Ischemic postconditioning (I-postC) can inhibit apoptosis of myocardial cells. Consequently, this study investigated the key genes and apoptosis signaling pathways of myocardium in patients undergoing CVRCPB.
Methods: A total of 36 New York Heart Association class II or III patients with rheumatic heart disease (RHD) of both sexes, aged 21-59 years, who were scheduled for first cardiac valve replacement with CPB in the investigators' hospital from February 2014 to May 2015, were randomly divided into the following three groups (n=12 each): negative control group (NEG group); I/R group (POS group); and I-postC group (Treat group). In the Treat group, the procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and cross-clamping for 30 s for three cycles, after which the ascending aorta was completely opened. The NEG and Treat groups were not treated. Thirty-six patients were assessed for arrhythmia and recovery of myocardial contractile function after reperfusion by electrocardiograms and degree of dependence on vasoactive drugs. The myocardial tissues of the right atrial appendage were obtained at 3 min before CPB was established in the NEG group, and at 45 min after opening the aorta in the POS and Treat groups. In all three groups, the myocardial tissues of the right atrial appendage were obtained and preserved at -80°C for further experiments. The right atrial appendage of three patients randomly selected in each group was fixed with RNA later (Qiagen, Hilden, Germany) in a centrifuge tube overnight at 4°C, and then preserved at -20°C for RNA extraction. Human 12×135K Gene Array profiling of mRNA expressions was undertaken in human cardiac muscle cells. Differentially expressed mRNAs verified by quantitative real-time RT-PCR were subjected to pathway analysis. The mRNA expressions of AIF, APAF1, CYCS, Bax, caspase-3, caspase-9, caspase-6, caspase-7, BCL2, BAG1, and PI3K were assessed by real-time RT-PCR and western blot analysis. The levels of myocardial apoptosis induced by I/R were investigated by TUNEL assays. The changes in MIRI induced by myocardial apoptosis were investigated by pathologic examination of the myocardium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| negative control group | No intervention | –The myocardial tissues of the right atrial appendage were obtained at 3 min before CPB was established in the NEG group. |
| I/R group | Active comparator | Procedure: Ischemic postconditioningThe myocardial tissues of the right atrial appendage were obtained at 45 min after opening the aorta in the I/R group. |
| I-postC group | Experimental | Procedure: Ischemic postconditioningThe procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and cross-clamping for 30 s for three cycles, after which the ascending aorta was completely opened. |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- New York Heart Association class II or III
- aged 21-59 years
- scheduled for first cardiac valve replacement with CPB
Key exclusion criteria (3 listed)
- The patient with a history of heart operation or diabetes,
- with a history of liver and/or kidney dysfunction,
- with a history of coronary heart disease and the left ventricular ejection fraction(LVEF)<0.4, receiving drugs with pretreatment effectssuchas hormones, ATP-sensitive potassium (KATP) channel openers,insulin,et al. within preoperative one week,
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 |
|---|---|---|
| Ischemic postconditioningAlso: The intervention is neither a drug nor a device. It is a procedure.In the Treat group, the procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and cross-clamping for 30 s for three cycles, after which the ascending aorta was completely opened. | Procedure or surgery | I-postC group, I/R group |
Primary outcome
recovery of myocardial contractile function after reperfusion
Time frame: 1 day
degree of dependence on vasoactive drugs
Time frame: 1 day
number of participants with postoperative arrhythmia
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic postconditioning in people with Ischemia-reperfusion(I/R) and Cardiopulmonarybypass, run by WANG Yan-bin 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 3 inclusion and 3 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 30 Apr 2015. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recovery of myocardial contractile function after reperfusion (time frame: 1 day). The study lists 3 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 30 Apr 2015.