Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG

AMIRI-CABG: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; CABG; Ischemic Heart Disease; Ischemic Reperfusion Injury
• Intervention / Treatment: Procedure: On-Pump CABG.; Procedure: Off-Pump CABG.; Procedure: BH-CABG MSC.

Detailed Description

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG is monitored by intraoperative measurement of serum level of myeloperoxidase before sternotomy and after sternal closure.

• Study Type: Observational
• Enrollment (Actual): 336

Contacts and Locations

Study Locations

• Russian Federation
  • St. Petersburg, Russian Federation, 197089
    • First Pavlov State Medical University of St. Petersburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic heart disease.

Description

Inclusion Criteria:

• ischemic heart disease

Exclusion Criteria:

• valve disease
• diabetes millitus

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
On-Pump CABG; Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass.	Procedure: On-Pump CABG.; Standard On-Pump CABG.
Off-Pump CABG; Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass.	Procedure: Off-Pump CABG.; Standard Off-Pump CABG.
BH-CABG MSC.; Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation.	Procedure: BH-CABG MSC.; Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myeloperoxidase	Level of serum myeloperoxidase just after sternal closure	Level of serum myeloperoxidase just after sternal closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Cardiac Output Syndrome	Low cardiac output syndrome up to 30 days after procedure. Cardiac index (CI) was measured by invasive methods. Low cardiac output syndrome was registered when CI <2.2.	Up to 30 days after surgical procedure
Length of Stay in Intensive Care Unit	Length of stay in intensive care unit after operation.	During 30 days after procedure or more
Length of Stay in Hospital	Length of stay in hospital	During 30 days after procedure or more
Cumulative Dose of Inotrope	Calculated according: Cumulative dose of inotrope = Days dose of inotrope * days of administration of inotrope	Up to 30 days after procedure
Days of Administration of Inotrope	Period of inotrope administration	During 30 days after procedure or more
Pulmonary Ventilation	Length of pulmonary ventilation	During 30 days after procedure or more
Systolic Function	Measured with echocardiography (Ejection Fraction)	Up to 14 days after surgical procedure
Diastolic Function	Measured with echocardiography (End-Diastolic Volume)	Up to 14 days after surgical procedure
Number of Participants With Reoperation	Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index<2.2.	Up to 30 days after procedure
Renal Dysfunction	Serum creatinine level after surgical operation larger than 25% level before operation	Perioperative (before sternotomy and after sternal closure)
Atrial Fibrillation.	New onset atrial fibrillation after operation.	Up to 30 days after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death after surgical procedure	During 30 days after procedure
Stroke	Stroke after surgical procedure	During 30 days after procedure

Collaborators and Investigators

• Sponsor: St. Petersburg State Pavlov Medical University
• Investigators: Study Director: Alexander S Nemkov, PhD, MD, PSPbGMU

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2015
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Ischemic Heart Disease; CABG; Off-Pump CABG; On-Pump CABG; ischemic-reperfusion injury during CABG; comparison of On- and Off- Pump CABG; Myocardial ischemia-reperfusion and myeloperoxidase; Myocardial ischemia-reperfusion biomarkers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Postoperative Complications; Coronary Disease; Cardiomyopathies; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Wounds and Injuries; Reperfusion Injury; Myocardial Reperfusion Injury
• Other Study ID Numbers: AMIRI-CABG 03/17-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No