NCT03500783

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 coronary-artery-disease

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

April 3, 2018

Last Update Submit

July 1, 2019

Conditions

Coronary Artery DiseaseCoronary Artery BypassCardiopulmonary BypassNitric OxideReperfusion Injury, Myocardial

Keywords

CardioprotectionIschemia-reperfusion injuryNitric oxideCardiopulmonary bypassCoronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 hours (with intermediate measurements at 6 and 24 hours)

Secondary Outcomes (2)

  • Creatine kinase-muscle/brain change measure (CK-MB)

    48 hours (with intermediate measurements at 6 and 24 hours)

  • Vasoactive inotropic score measure (VIS)

    48 hours (with intermediate measurements at 6 and 24 hours)

Study Arms (2)

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.

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.

Other: Standard CPB

Interventions

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.

Nitric Oxide
Standard CPBOTHER

Standard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit

Also known as: Cardiopulmonary bypass
Standard CPB

Eligibility Criteria

Age56 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary artery disease requiring coronary artery bypass grafting with the cardiopulmonary bypass.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Reperfusion InjuryReperfusion Injury

Interventions

Nitric OxideCardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiomyopathiesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic ChemicalsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Sergey V Popov, MD

    Tomsk NRMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Trial participants, data analysts, and report writers are blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single-center prospective, randomized, placebo-controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physician Anesthesiologist

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 18, 2018

Study Start

May 15, 2015

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
Access Criteria
Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.