Coronary Artery DiseasePhase 1/2NOinCPBNCT03500783
Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
A Phase 1/2 study testing Nitric Oxide and Standard CPB in people with Coronary Artery Disease and Coronary Artery Bypass, run by Tomsk National Research Medical Center of the Russian Academy of Sciences.
Trial summary
This prospective randomized study elucidates the effects of exogenous nitric oxide delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 56 to 65 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass, Cardiopulmonary Bypass
- What is being tested?
- Nitric Oxide and Standard CPB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2015to 30 Nov 2016
- Phase
- Phase 1/2
- 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 56 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery disease requiring coronary artery bypass grafting with the cardiopulmonary bypass.
Who cannot join
- Non-elective surgery, age over 70 years, left ventricular ejection fraction less than 35%, history of myocardial infarction within three months prior to surgery, chronic atrial fibrillation, diabetes mellitus, and the elevated levels of cardiac specific markers within 12 h prior to the intervention.
About this study
This prospective randomized study elucidates the effects of exogenous nitric oxide delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery with cardiopulmonary bypass.
Read the detailed description
The aim of this study is to investigate the effects of exogenous nitric oxide (NO) delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery (CABG) with cardiopulmonary bypass (CPB). A total of 60 patients with ischemic heart disease referred for CABG with CPB are included in prospective randomized study. Patients are randomized to receive standard treatment or surgery based on modified CPB protocol. According to modified protocol, 40-ppm NO is supplied to the CPB circuit during CABG. The primary endpoints are changes in cardiac troponin I (cTnI) levels at 6, 24, and 48 hours after surgery compared with baseline. The secondary end points are the changes in the levels of creatine kinase-muscle/brain (CK-MB) compared with baseline and vasoactive inotropic score (VIS) at 6, 24, and 48 hours. NO supplied to the CPB circuit exertes cardioprotective effect. Changes in cTnI, CK-MB, and VIS are considered indictors of the presence or absence of cardioprotective action of NO supplied to the CPB circuit.
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass, Cardiopulmonary Bypass, Nitric Oxide, Reperfusion Injury, Myocardial
- Being tested
- Nitric Oxide, Standard CPB
- Keywords
- Cardioprotection, Ischemia-reperfusion injury, Nitric oxide, Cardiopulmonary bypass, Coronary artery bypass grafting
- Medical subject headings
- Coronary Artery Disease, Myocardial Reperfusion Injury, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting.
Standard CPBOther
Also called Cardiopulmonary bypass
Standard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide | Experimental | Patients of this group receive treatment with exogenous gaseous nitric oxide supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting for coronary artery disease. Receives: Drug: Nitric Oxide |
| Standard CPB | Placebo comparator | Patients of this group receive sham-treatment without supplying nitric oxide to the cardiopulmonary bypass circuit during coronary artery bypass grafting for coronary artery disease. Considering dilution of nitric oxide at a high ratio of 1 to 25,000 in the gas mixture of the cardiopulmonary bypass circuit (CPB), no addition of any inert gas to the CPB circuit is required in sham-treatment group. Receives: Other: Standard CPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac troponin I change measure (cTnI)
Changes in the plasma level of cTnI (ng/mL) relative to the baseline value are measured at 6, 24, and 48 hours after surgery.
Measured: 48 hours (with intermediate measurements at 6 and 24 hours)
Secondary outcomes (2)
Creatine kinase-muscle/brain change measure (CK-MB)
Changes in the plasma level of CK-MB (U/L) relative to the baseline value are measured at 6, 24, and 48 hours after surgery.
Measured: 48 hours (with intermediate measurements at 6 and 24 hours)
Vasoactive inotropic score measure (VIS)
Vasoactive inotropic score (VIS) is assessed at 6, 24, and 48 hours after surgery. VIS is calculated as follows: (dobutamine μg/kg/min × 1 + dopamine μg/kg/min × 1 + milrinone μg/kg/min × 10) + 100 × (adrenalin μg/kg/min + noradrenaline μg/kg/min + vasopressin μg/kg/min).
Measured: 48 hours (with intermediate measurements at 6 and 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start15 May 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center prospective, randomized, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolay Kamenshchikov, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Sergey V Popov, MD, Study director, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500783
- Sponsor's protocol ID
- CRI-133
- Acronym
- NOinCPB
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2018
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03500783
- Acronym / sponsor ID
- NOinCPB / CRI-133
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass, Cardiopulmonary Bypass, Nitric Oxide, Reperfusion Injury, Myocardial
- Keywords
- Cardioprotection, Ischemia-reperfusion injury, Nitric oxide, Cardiopulmonary bypass, Coronary artery bypass grafting
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 15 May 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 18 Apr 2018 (actual)
- 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.
This prospective randomized study elucidates the effects of exogenous nitric oxide delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery with cardiopulmonary bypass.
Detailed description
The aim of this study is to investigate the effects of exogenous nitric oxide (NO) delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery (CABG) with cardiopulmonary bypass (CPB). A total of 60 patients with ischemic heart disease referred for CABG with CPB are included in prospective randomized study. Patients are randomized to receive standard treatment or surgery based on modified CPB protocol. According to modified protocol, 40-ppm NO is supplied to the CPB circuit during CABG. The primary endpoints are changes in cardiac troponin I (cTnI) levels at 6, 24, and 48 hours after surgery compared with baseline. The secondary end points are the changes in the levels of creatine kinase-muscle/brain (CK-MB) compared with baseline and vasoactive inotropic score (VIS) at 6, 24, and 48 hours. NO supplied to the CPB circuit exertes cardioprotective effect. Changes in cTnI, CK-MB, and VIS are considered indictors of the presence or absence of cardioprotective action of NO supplied to the CPB circuit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center prospective, randomized, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide | Experimental | Drug: Nitric OxidePatients of this group receive treatment with exogenous gaseous nitric oxide supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting for coronary artery disease. |
| Standard CPB | Placebo comparator | Other: Standard CPBPatients of this group receive sham-treatment without supplying nitric oxide to the cardiopulmonary bypass circuit during coronary artery bypass grafting for coronary artery disease. Considering dilution of nitric oxide at a high ratio of 1 to 25,000 in the gas mixture of the cardiopulmonary bypass circuit (CPB), no addition of any inert gas to the CPB circuit is required in sham-treatment group. |
Who may qualify
- Ages
- 56 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary artery disease requiring coronary artery bypass grafting with the cardiopulmonary bypass.
Key exclusion criteria (1 listed)
- Non-elective surgery, age over 70 years, left ventricular ejection fraction less than 35%, history of myocardial infarction within three months prior to surgery, chronic atrial fibrillation, diabetes mellitus, and the elevated levels of cardiac specific markers within 12 h prior to the intervention.
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 |
|---|---|---|
| Nitric Oxide40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting. | Drug | Nitric Oxide |
| Standard CPBAlso: Cardiopulmonary bypassStandard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit | Other | Standard CPB |
Primary outcome
Cardiac troponin I change measure (cTnI)
Time frame: 48 hours (with intermediate measurements at 6 and 24 hours)
Changes in the plasma level of cTnI (ng/mL) relative to the baseline value are measured at 6, 24, and 48 hours after surgery.
2 secondary outcomes
Creatine kinase-muscle/brain change measure (CK-MB)
Time frame: 48 hours (with intermediate measurements at 6 and 24 hours)
Vasoactive inotropic score measure (VIS)
Time frame: 48 hours (with intermediate measurements at 6 and 24 hours)
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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
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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.
Sergey V Popov, MD study director
Tomsk NRMC
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitric Oxide and Standard CPB in people with Coronary Artery Disease and Coronary Artery Bypass, run by Tomsk National Research Medical Center of the Russian Academy of Sciences.
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 1 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiac troponin I change measure (cTnI) (time frame: 48 hours (with intermediate measurements at 6 and 24 hours)). 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 21 Oct 2026.