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NCT03786965 Clinical Trial

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

Ischemic Heart Disease Clinical Trial

— MPO-CSP  

Official title:
Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03786965
Other study ID # ?22/18-H
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2018
Est. completion date December 20, 2025

Study information
Verified date November 2021
Source St. Petersburg State Pavlov Medical University
Contact Alexander Nemkov, PhD
Phone +7-921-795-00-47
Email nemk_as@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 20, 2025
Est. primary completion date July 20, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• On-pump CABG
On-pump CABG
• Off-pump CABG
Off-pump CABG
• Pump-assisted CABG
Pump-assisted CABG
• Valve Repair Procedure without CABG.
Valve Repair Procedure without CABG (open heart procedure).
• Valve Repair Procedure with CABG.
Valve Repair Procedure with CABG (open heart procedure).

Locations
Country Name City State
Russian Federation Nikolai Bunenkov Saint-Petersburg Non-US/Non-Canadian

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