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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050489
• Other study ID #: AMIRI-CABG 03/17-11
• Status: Completed
• Start date: September 15, 2015
• Est. completion date: May 31, 2019

Study information

• Verified date: April 2022
• Source: St. Petersburg State Pavlov Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• ischemic heart disease

Exclusion Criteria:

• valve disease

• diabetes millitus

Related Conditions & MeSH terms

• CABG
• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Ischemic Reperfusion Injury
• Myocardial Ischemia
• Myocardial Reperfusion Injury
• Reperfusion Injury
• Wounds and Injuries

Intervention

Procedure:
• On-Pump CABG.
Standard On-Pump CABG.
• 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

Locations

Country	Name	City	State
Russian Federation	First Pavlov State Medical University of St. Petersburg	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	Death after surgical procedure	During 30 days after procedure
Other	Stroke	Stroke after surgical procedure	During 30 days after procedure
Primary	Myeloperoxidase	Level of serum myeloperoxidase just after sternal closure	Level of serum myeloperoxidase just after sternal closure
Secondary	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
Secondary	Length of Stay in Intensive Care Unit	Length of stay in intensive care unit after operation.	During 30 days after procedure or more
Secondary	Length of Stay in Hospital	Length of stay in hospital	During 30 days after procedure or more
Secondary	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
Secondary	Days of Administration of Inotrope	Period of inotrope administration	During 30 days after procedure or more
Secondary	Pulmonary Ventilation	Length of pulmonary ventilation	During 30 days after procedure or more
Secondary	Systolic Function	Measured with echocardiography (Ejection Fraction)	Up to 14 days after surgical procedure
Secondary	Diastolic Function	Measured with echocardiography (End-Diastolic Volume)	Up to 14 days after surgical procedure
Secondary	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
Secondary	Renal Dysfunction	Serum creatinine level after surgical operation larger than 25% level before operation	Perioperative (before sternotomy and after sternal closure)
Secondary	Atrial Fibrillation.	New onset atrial fibrillation after operation.	Up to 30 days after procedure