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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Shenzhen SUN Yat-Sen Cardiovascular hospital

    Shenzhen

    Yanbin Wang, Master of Medicine, +8615816886696, wangyb666@126.com

    Recruiting

Other trials in China

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.

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 groups in NCT02430116
Study groupRoleWhat they receive
negative control groupNo interventionThe myocardial tissues of the right atrial appendage were obtained at 3 min before CPB was established in the NEG group.
I/R groupActive comparatorThe 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 groupExperimentalThe 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.

  1. recovery of myocardial contractile function after reperfusion

    Measured: 1 day

  2. degree of dependence on vasoactive drugs

    Measured: 1 day

  3. 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.

  1. First posted30 Apr 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionMay 2015 (estimated)

Resources

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)
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

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.

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