Clinical trial NCT03500783: Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
Official title: Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 56
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center prospective, randomized, placebo-controlled study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cardiac troponin I change measure (cTnI)
timeFrame: 48 hours (with intermediate measurements at 6 and 24 hours)
Secondary outcomes:
measure: Creatine kinase-muscle/brain change measure (CK-MB)
timeFrame: 48 hours (with intermediate measurements at 6 and 24 hours)
measure: Vasoactive inotropic score measure (VIS)
timeFrame: 48 hours (with intermediate measurements at 6 and 24 hours)
Other outcomes:
Locations:
Study officials:
affiliation: Tomsk NRMC
name: Sergey V Popov, MD
role: STUDY_DIRECTOR
References: