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Completed

NCT Number: NCT03050489

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

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

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Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis CABG Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Ischemic Reperfusion Injury Myocardial Ischemia Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197089, Russia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ischemic heart disease

Exclusion criteria

  • valve disease
  • diabetes millitus

Treatment and study plan

On-Pump CABG.

Procedure

Standard On-Pump CABG.

Off-Pump CABG.

Procedure

Standard Off-Pump CABG.

BH-CABG MSC.

Procedure

Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation

Primary outcomes

  1. Myeloperoxidase

    Time frame: Level of serum myeloperoxidase just after sternal closure

    Level of serum myeloperoxidase just after sternal closure

Secondary outcomes

  1. Low Cardiac Output Syndrome

    Time frame: Up to 30 days after surgical procedure

    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.

  2. Length of Stay in Intensive Care Unit

    Time frame: During 30 days after procedure or more

    Length of stay in intensive care unit after operation.

  3. Length of Stay in Hospital

    Time frame: During 30 days after procedure or more

    Length of stay in hospital

  4. Cumulative Dose of Inotrope

    Time frame: Up to 30 days after procedure

    Calculated according: Cumulative dose of inotrope = Days dose of inotrope * days of administration of inotrope

  5. Days of Administration of Inotrope

    Time frame: During 30 days after procedure or more

    Period of inotrope administration

  6. Pulmonary Ventilation

    Time frame: During 30 days after procedure or more

    Length of pulmonary ventilation

  7. Systolic Function

    Time frame: Up to 14 days after surgical procedure

    Measured with echocardiography (Ejection Fraction)

  8. Diastolic Function

    Time frame: Up to 14 days after surgical procedure

    Measured with echocardiography (End-Diastolic Volume)

  9. Number of Participants With Reoperation

    Time frame: Up to 30 days after procedure

    Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index<2.2.

  10. Renal Dysfunction

    Time frame: Perioperative (before sternotomy and after sternal closure)

    Serum creatinine level after surgical operation larger than 25% level before operation

  11. Atrial Fibrillation.

    Time frame: Up to 30 days after procedure

    New onset atrial fibrillation after operation.

Other outcomes

  1. Death

    Time frame: During 30 days after procedure

    Death after surgical procedure

  2. Stroke

    Time frame: During 30 days after procedure

    Stroke after surgical procedure

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2017
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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