Cardiopulmonary BypassNCT01804283
Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement
A study testing ischemic postconditioning, double valve replacement and heart-lung machine in people with Cardiopulmonary Bypass and Ischemic Postconditioning, run by Central South University at 1 site in China.
Trial summary
1. Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in patients undergoing double valve replacement (aortic and mitral). 2. The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest may be rescued by ischemic postconditioning. 3. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiopulmonary Bypass, Ischemic Postconditioning
- What is being tested?
- ischemic postconditioning, double valve replacement and heart-lung machine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Mar 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive eight patients with rheumatic heart valve disease undergoing elective double valve replacement(aortic and mitral)are considered for participation in this study.
Who cannot join
- insulin-dependent diabetes mellitus
- pulmonary, renal, or hepatic failure
- infective valve disease
- valve disease with coronary artery disease
- hypertension
- emergency and reoperations
- received aspirin,corticosteroids, or statin preoperatively
- received preoperative inotropic support
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital
Changsha, Hunan, 410008
Wanjun Luo, MD, 86-731-89753003, luo3478@yahoo.cn
Wanjun Luo, MD
About this study
Official title: Effects of Ischemic Postconditioning on Expression of Apoptosis-related MicroRNAs and Genes in Human Double Valve Replacement
- Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in patients undergoing double valve replacement (aortic and mitral).
- The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest may be rescued by ischemic postconditioning.
- Downstream effectors would also be affected.
- Conditions
- Cardiopulmonary Bypass, Ischemic Postconditioning
- Being tested
- ischemic postconditioning, double valve replacement, heart-lung machine, Aortic cross-clamp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic postconditioningProcedure or surgery
multiple brief ischemic-reperfusion episodes immediately after sustained ischemic insult
Postconditioning was started at 30 s after aortic cross declamping, and the aorta was re-clamped for 30 s rendering global myocardial ischemia. Meanwhile aortic root suction was established during aortic re-clamping, and thereafter, the aortic clamp was released for 30 s for full myocardial reperfusion. The cycle was repeated three times after cardioplegic arrest.
double valve replacementProcedure or surgery
The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.
heart-lung machineDevice
The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.
Aortic cross-clampDevice
a surgical instrument used in cardiac surgery to clamp the aorta
| Study group | Role | What they receive |
|---|---|---|
| CON | Sham comparator | Patients undergoing double valve replacement (aortic and mitral). Receives: Procedure: double valve replacement; Device: heart-lung machine; Device: Aortic cross-clamp |
| IPO | Experimental | Patients undergoing double valve replacement (aortic and mitral) with ischemic postconditioning. Receives: Procedure: ischemic postconditioning; Procedure: double valve replacement; Device: heart-lung machine; Device: Aortic cross-clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Cardiac MicroRNA Expression
Samples were harvested from all the patients, respectively, before cardiopulmonary bypass and at 5 min after aortic de-clamping. Real-time quantitative stem-loop reverse transcription polymerase chain reaction assay was performed to detect the expression of microRNAs.
Measured: before cardiopulmonary bypass and at 5 min after aortic de-clamping
Secondary outcomes (1)
Change from Baseline in Downstream Gene Expression
Expressions of messenger RNAs and proteins were quantified for genes which are regulated by above-detected microRNAs.
Measured: before cardiopulmonary bypass and at 5 min after aortic de-clamping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo Wanjun, Central South University
- Investigators
- Wanjun Luo, MD, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804283
- Sponsor's protocol ID
- CmiR-001
- Status last verified
- Mar 2013
- First submitted
- 23 Feb 2013
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gao Y, Huang R, Chen R, Li J, Luo W. Ischemic postconditioning altered microRNAs in human valve replacement. J Surg Res. 2016 Jan;200(1):28-35. doi: 10.1016/j.jss.2015.07.010. Epub 2015 Jul 10.
PubMed 26253453
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ischemic Postconditioning on Expression of Apoptosis-related MicroRNAs and Genes in Human Double Valve Replacement
- ClinicalTrials.gov ID
- NCT01804283
- Acronym / sponsor ID
- CmiR-001
- Conditions
- Cardiopulmonary Bypass, Ischemic Postconditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (estimated)
- First posted
- 5 Mar 2013 (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.
- Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in patients undergoing double valve replacement (aortic and mitral).
- The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest may be rescued by ischemic postconditioning.
- Downstream effectors would also be affected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CON | Sham comparator | Procedure: double valve replacement, Device: heart-lung machine, Device: Aortic cross-clampPatients undergoing double valve replacement (aortic and mitral). |
| IPO | Experimental | Procedure: ischemic postconditioning, Procedure: double valve replacement, Device: heart-lung machine, Device: Aortic cross-clampPatients undergoing double valve replacement (aortic and mitral) with ischemic postconditioning. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive eight patients with rheumatic heart valve disease undergoing elective double valve replacement(aortic and mitral)are considered for participation in this study.
Key exclusion criteria (8 listed)
- insulin-dependent diabetes mellitus
- pulmonary, renal, or hepatic failure
- infective valve disease
- valve disease with coronary artery disease
- hypertension
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 postconditioningmultiple brief ischemic-reperfusion episodes immediately after sustained ischemic insult Postconditioning was started at 30 s after aortic cross declamping, and the aorta was re-clamped for 30 s rendering global myocardial ischemia. Meanwhile aortic root suction was established during aortic re-clamping, and thereafter, the aortic clamp was released for 30 s for full myocardial reperfusion. The cycle was repeated three times after cardioplegic arrest. | Procedure or surgery | IPO |
| double valve replacementThe double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves. | Procedure or surgery | CON, IPO |
| heart-lung machineThe heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation. | Device | CON, IPO |
| Aortic cross-clampa surgical instrument used in cardiac surgery to clamp the aorta | Device | CON, IPO |
Primary outcome
Change from Baseline in Cardiac MicroRNA Expression
Time frame: before cardiopulmonary bypass and at 5 min after aortic de-clamping
Samples were harvested from all the patients, respectively, before cardiopulmonary bypass and at 5 min after aortic de-clamping. Real-time quantitative stem-loop reverse transcription polymerase chain reaction assay was performed to detect the expression of microRNAs.
1 secondary outcome
Change from Baseline in Downstream Gene Expression
Time frame: before cardiopulmonary bypass and at 5 min after aortic de-clamping
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Derived from this study: PubMed 26253453Gao Y, Huang R, Chen R, Li J, Luo W. Ischemic postconditioning altered microRNAs in human valve replacement. J Surg Res. 2016 Jan;200(1):28-35. doi: 10.1016/j.jss.2015.07.010. Epub 2015 Jul 10.
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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.
Wanjun Luo, MD principal investigator
Xiangya Hospital of Central South 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 ischemic postconditioning, double valve replacement and heart-lung machine in people with Cardiopulmonary Bypass and Ischemic Postconditioning, run by Central South University 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 8 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 5 Mar 2013. 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?
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?
Change from Baseline in Cardiac MicroRNA Expression (time frame: before cardiopulmonary bypass and at 5 min after aortic de-clamping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804283, which also lists 1 linked publication.
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 5 Mar 2013.