Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.

Not Applicable

Recruiting

• Conditions: Cardiac Procedure Complication; Ischemic Heart Disease; Valve Heart Disease; Defect Septal
• Interventions: Other: Off-pump CABG; Other: On-pump CABG; Other: Pump-assisted CABG; Other: Valve Repair Procedure without CABG.; Other: Valve Repair Procedure with CABG.

• Registration Number: NCT03786965
• Lead Sponsor: St. Petersburg State Pavlov Medical University

Brief Summary

The main objection is to investigate molecular biology of myocardial damage during cardiac surgery procedures.

Detailed Description

To assess outcomes after cardiac surgery procedures. To investigate serum level of myeloperoxidase, morphology of left atrium appendage, to perform genetic analysis and cell biology.

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-26
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-14
• Last Update Posted: 2021-11-16
• Primary Completion: 2025-07-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• ischemic heart disease with indications for operation
• valve disease with indications for operation
• ischemic heart disease combined with valve disease with indications for operation

Exclusion Criteria

• patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Off-pump CABG.	Off-pump CABG	Off-pump CABG.
On-pump CABG.	On-pump CABG	On-pump CABG.
Pump-assisted CABG.	Pump-assisted CABG	Pump-assisted CABG.
Heart Valve Procedure without CABG.	Valve Repair Procedure without CABG.	Heart Valve Procedure without CABG.
Heart Valve Procedure with CABG.	Valve Repair Procedure with CABG.	Heart Valve Procedure with CABG.

Primary Outcome Measures

Name	Time	Method
Stroke.	within 30 days after procedure.	Stroke (MRI changes or corresponding neurologist record).
Infection or febrile.	within 30 days after procedure.	Infection or febrile (t\> 37 or CRP elevation or long regeneration of surgical wound).
Respiratory dysfunction.	within 30 days after procedure.	Respiratory dysfunction (pulmonary ventilation longer than 2 days).
Death within 30 days after procedure.	within 30 days after procedure.	Death within 30 days after surgical procedure.
Acute myocardial infarction.	within 30 days after procedure.	Acute myocardial infarction (ST-changes with troponin I \> 10 ng/ml).
Renal dysfunction.	within 30 days after procedure.	Renal dysfunction if serum creatinine greater than 25% of upper reference range.
Arrhythmia	within 30 days after procedure.	Any type of arrhythmia including AV-block.

Trial Locations

Locations (1)

Nikolai Bunenkov; 🇷🇺 Saint-Petersburg, Non-US/Non-Canadian, Russian Federation