Coronary Artery Bypass Graft Triple VesselPhase 4NCT02678650
MicroRNA Mediates Volatile Anesthetics Preconditioning Induced Artery Protection
A Phase 4 study testing volatile anesthetics(isoflurane) and propofol intravenous anesthesia in people with Coronary Artery Bypass Graft Triple Vessel, run by Liang Zhang at 1 site in China.
Trial summary
It has been reported that volatile anesthetics preconditioning mediates protection of organ via microRNA. We want to study on the effects of isoflurane preconditioning on expression of microRNA and mRNA in the specimens of internal mammary artery and ascending aorta. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Bypass Graft Triple Vessel
- What is being tested?
- volatile anesthetics(isoflurane) and propofol intravenous anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2017
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years
- written informed consent;
- scheduled procedures;
- planned isolated OPCABG(multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed);
- ejection fraction> 50%;
- NYHA class Ⅱ~Ⅲ;
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- serum creatinine <150μmol / l;
- preoperative platelet content > 100 × 109 / l;
- preoperative hemoglobin> 120 g / l
Who cannot join
- pregnancy;
- planned valve surgery or surgery on the aorta;
- left main coronary artery stenosis> 75%;
- echocardiographic examination revealed moderate to severe mitral, tricuspid, or aortic regurgitation or stenosis;
- unstable or ongoing angina;
- recent (< 1 month) or ongoing acute myocardial infarction;
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- use of sulfonylurea, theophylline or allopurinol;
- previous unusual response to an anesthetic agent;
- inclusion in other randomised controlled studies in the previous 30 days; (10)any general anesthesia performed in the previous 30 days;
- emergency operation (not scheduled);
- kidney or liver transplant in medical history, liver cirrhosis (Child B or C);
- chronic respiratory disease (such as chronic obstructive pulmonary emphysema)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100038
Jun Ma, MD, 010-64456329, majun7689@163.com
About this study
Official title: Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University
It has been reported that volatile anesthetics preconditioning mediates protection of organ via microRNA. We want to study on the effects of isoflurane preconditioning on expression of microRNA and mRNA in the specimens of internal mammary artery and ascending aorta.
Read the detailed description
- Sixty patients scheduled for off-pump coronary artery bypass surgery were randomly assigned to isoflurane wash-in/wash-out group(S-I group, n=30)or propofol intravenous anesthesia group(P group, n=30).
- Anesthesia and monitoring method All patients were monitored according to the American Society of Anesthesia guidelines and received standard general induction of anesthesia.
- SI group:10min after intubation,begin to isoflurane wash-in/wash-out operation:isoflurane administration was interrupted for at least 10 min,by washout with a high fresh gas flow(10 l/min)to achieve a MAC value below 0.2. Following the interruption,sevoflurane was again washed in with a high fresh gas flow(6 l/min)to achieve 1 MAC end-tidal concentration as soon as possible,and repeated twice periods of 10 minutes.Discontinuation of the halogenated agent for at least 15 minutes during the last wash out time.
- P Group:propofol infusion 3-5μg/kg/h.
- When isoflurane inhaled anesthetic,propofol are stopped infusion.If during this interruption the BIS value increased to>50,0.5 mg/kg propofol was administered repeatedly in boluses until the BIS value have returned to<50.
6.1h after isoflurane preconditioning,specimens of internal mammary artery(surplus arterial tissue is obtained from the repair internal mammary artery)and ascending aorta(the stump after ascending aortic punch)will be saved, and before isoflurane preconditioning,1h,3h,5h after isoflurane preconditioning, central venous blood samples will also be drawn.
- Being tested
- volatile anesthetics(isoflurane), propofol intravenous anesthesia
- Keywords
- Volatile Anesthetics, MicroRNA, Off-pump Coronary Artery Bypass Surgery, Internal Mammary Artery, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volatile anesthetics(isoflurane)Drug
volatile anesthetics wash-in / wash-out operation
propofol intravenous anesthesiaDrug
propofol infusion 3-5μg / kg / h
| Study group | Role | What they receive |
|---|---|---|
| volatile anesthetics group | Experimental | 10min after intubation, begin to sevoflurane wash-in / wash-out operation: sevoflurane administration was interrupted for at least 10 min, by washout with a high fresh gas flow (10 l/min) to achieve a MAC value below 0.2. Following the interruption, sevoflurane was again washed in with a high fresh gas flow (6 l/min) to achieve 1 MAC end-tidal concentration as soon as possible, and repeated twice periods of 10 minutes. Discontinuation of the halogenated agent for at 15 minutes during the last wash out time. Receives: Drug: volatile anesthetics(isoflurane) |
| propofol intravenous anesthesia group | Placebo comparator | propofol infusion 3-5μg / kg / h Receives: Drug: propofol intravenous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA
Measured: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
NOS3 mRNA,mRNA levels of adhesion molecule selectin -E,vascular cell adhesion molecule -1,vascular endothelial growth factor -1,intercellular adhesion molecule,RhoA and ROK
Measured: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
phosphatidylinositol-3-kinase,alanine aminotransferase,endothelial nitric oxide synthase
Measured: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
Secondary outcomes (3)
Change from microRNA
Measured: befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)
Change from ON content in serum,vascular cell adhesion molecule-1,intercellular adhesion molecules-1,adhesion molecule selectin-E,monocyte chemoattractant protein-1 and vascular endothelial growth factor-1
Measured: befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)
Change from tumor necrosis factor-a,interleukin 1β,IL-6,IL-8 and IL-10
Measured: befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (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 Coronary Artery Bypass Graft Triple VesselStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liang Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liang Zhang, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678650
- Sponsor's protocol ID
- 2015017X
- Status last verified
- Feb 2016
- First submitted
- 23 Jan 2016
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zhang L, Wang CB, Li B, Lin DM, Ma J. RhoA/rho-kinase, nitric oxide and inflammatory response in LIMA during OPCABG with isoflurane preconditioning. J Cardiothorac Surg. 2019 Jan 25;14(1):22. doi: 10.1186/s13019-019-0835-9.
PubMed 30683137
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University
- ClinicalTrials.gov ID
- NCT02678650
- Acronym / sponsor ID
- 2015017X
- Keywords
- Volatile Anesthetics, MicroRNA, Off-pump Coronary Artery Bypass Surgery, Internal Mammary Artery, Ascending Aorta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liang ZhangUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 10 Feb 2016 (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.
It has been reported that volatile anesthetics preconditioning mediates protection of organ via microRNA. We want to study on the effects of isoflurane preconditioning on expression of microRNA and mRNA in the specimens of internal mammary artery and ascending aorta.
Detailed description
- Sixty patients scheduled for off-pump coronary artery bypass surgery were randomly assigned to isoflurane wash-in/wash-out group(S-I group, n=30)or propofol intravenous anesthesia group(P group, n=30).
- Anesthesia and monitoring method All patients were monitored according to the American Society of Anesthesia guidelines and received standard general induction of anesthesia.
- SI group:10min after intubation,begin to isoflurane wash-in/wash-out operation:isoflurane administration was interrupted for at least 10 min,by washout with a high fresh gas flow(10 l/min)to achieve a MAC value below 0.2. Following the interruption,sevoflurane was again washed in with a high fresh gas flow(6 l/min)to achieve 1 MAC end-tidal concentration as soon as possible,and repeated twice periods of 10 minutes.Discontinuation of the halogenated agent for at least 15 minutes during the last wash out time.
- P Group:propofol infusion 3-5μg/kg/h.
- When isoflurane inhaled anesthetic,propofol are stopped infusion.If during this interruption the BIS value increased to>50,0.5 mg/kg propofol was administered repeatedly in boluses until the BIS value have returned to<50.
6.1h after isoflurane preconditioning,specimens of internal mammary artery(surplus arterial tissue is obtained from the repair internal mammary artery)and ascending aorta(the stump after ascending aortic punch)will be saved, and before isoflurane preconditioning,1h,3h,5h after isoflurane preconditioning, central venous blood samples will also be drawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| volatile anesthetics group | Experimental | Drug: volatile anesthetics(isoflurane)10min after intubation, begin to sevoflurane wash-in / wash-out operation: sevoflurane administration was interrupted for at least 10 min, by washout with a high fresh gas flow (10 l/min) to achieve a MAC value below 0.2. Following the interruption, sevoflurane was again washed in with a high fresh gas flow (6 l/min) to achieve 1 MAC end-tidal concentration as soon as possible, and repeated twice periods of 10 minutes. Discontinuation of the halogenated agent for at 15 minutes during the last wash out time. |
| propofol intravenous anesthesia group | Placebo comparator | Drug: propofol intravenous anesthesiapropofol infusion 3-5μg / kg / h |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age >18 years
- written informed consent;
- scheduled procedures;
- planned isolated OPCABG(multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed);
- ejection fraction> 50%;
Key exclusion criteria (12 listed)
- pregnancy;
- planned valve surgery or surgery on the aorta;
- left main coronary artery stenosis> 75%;
- echocardiographic examination revealed moderate to severe mitral, tricuspid, or aortic regurgitation or stenosis;
- unstable or ongoing angina;
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 |
|---|---|---|
| volatile anesthetics(isoflurane)volatile anesthetics wash-in / wash-out operation | Drug | volatile anesthetics group |
| propofol intravenous anesthesiapropofol infusion 3-5μg / kg / h | Drug | propofol intravenous anesthesia group |
Primary outcome
microRNA
Time frame: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
NOS3 mRNA,mRNA levels of adhesion molecule selectin -E,vascular cell adhesion molecule -1,vascular endothelial growth factor -1,intercellular adhesion molecule,RhoA and ROK
Time frame: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
phosphatidylinositol-3-kinase,alanine aminotransferase,endothelial nitric oxide synthase
Time frame: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
3 secondary outcomes
Change from microRNA
Time frame: befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)
Change from ON content in serum,vascular cell adhesion molecule-1,intercellular adhesion molecules-1,adhesion molecule selectin-E,monocyte chemoattractant protein-1 and vascular endothelial growth factor-1
Time frame: befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)
Change from tumor necrosis factor-a,interleukin 1β,IL-6,IL-8 and IL-10
Time frame: befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Derived from this study: PubMed 30683137Zhang L, Wang CB, Li B, Lin DM, Ma J. RhoA/rho-kinase, nitric oxide and inflammatory response in LIMA during OPCABG with isoflurane preconditioning. J Cardiothorac Surg. 2019 Jan 25;14(1):22. doi: 10.1186/s13019-019-0835-9.
- Individual participant dataSharing planned: Undecided
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 Phase 4 study testing volatile anesthetics(isoflurane) and propofol intravenous anesthesia in people with Coronary Artery Bypass Graft Triple Vessel, run by Liang Zhang 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 9 inclusion and 12 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 10 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jun Ma, MD (010-64456329, majun7689@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNA (time frame: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)). 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?
On the ClinicalTrials.gov record for NCT02678650, 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 10 Feb 2016.