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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050489
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
St. Petersburg State Pavlov Medical University

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

Condition or disease Intervention/treatment
Ischemic Heart Disease Coronary Artery Disease Ischemic Reperfusion Injury CABG 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.

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Study Type : Observational
Actual Enrollment : 336 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AMIRI-CABG: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
Actual Study Start Date : September 15, 2015
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

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




Primary Outcome Measures :
  1. Myeloperoxidase [ Time Frame: Perioperative (before sternotomy and after sternal closure) ]
    Level of serum myeloperoxidase before and just after surgical procedure


Secondary Outcome Measures :
  1. Low cardiac output syndrome [ Time Frame: During 30 days after surgical procedure ]
    Low cardiac output syndrome during surgical procedure or within 30 days after procedure.

  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: During 30 days after procedure or more ]
    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: Before and after surgical procedure ]
    Measured with echocardiography (End-Systolic Volume, Ejection Fraction)

  8. Diastolic function [ Time Frame: Before and after surgical procedure ]
    Measured with echocardiography (End-Diastolic Volume)

  9. Reoperation [ Time Frame: During 30 days after procedure ]
    Reoperation due to cardiac complication

  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: During 30 days after procedure ]
    New onset atrial fibrillation after operation.


Other Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
Serum from central vein.


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with ischemic heart disease.
Criteria

Inclusion Criteria:

  • ischemic heart disease

Exclusion Criteria:

  • valve disease
  • diabetes millitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050489


Locations
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Russian Federation
First Pavlov State Medical University of St. Petersburg
St. Petersburg, Russian Federation, 197089
Sponsors and Collaborators
St. Petersburg State Pavlov Medical University
Investigators
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Study Director: Alexander S Nemkov, PhD, MD PSPbGMU
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Responsible Party: St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT03050489    
Other Study ID Numbers: AMIRI-CABG 03/17-11
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Petersburg State Pavlov Medical University:
CABG
Off-Pump CABG
On-Pump CABG
ischemic-reperfusion injury during CABG
comparison of On- and Off- Pump CABG
Ischemic Heart Disease
Myocardial ischemia-reperfusion and myeloperoxidase
Myocardial ischemia-reperfusion biomarkers
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Reperfusion Injury
Myocardial Reperfusion Injury
Ischemia
Wounds and Injuries
Pathologic Processes
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Postoperative Complications
Cardiomyopathies