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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03050489
Other study ID # AMIRI-CABG 03/17-11
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
Gender All
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria: - ischemic heart disease Exclusion Criteria: - valve disease - diabetes millitus

Study Design


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
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