Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures. (MPO-CSP)

November 14, 2021 updated by: Aleksandr Nemkov, St. Petersburg State Pavlov Medical University
The main objection is to investigate molecular biology of myocardial damage during cardiac surgery procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Non-US/Non-Canadian
      • Saint-Petersburg, Non-US/Non-Canadian, Russian Federation, 194358
        • Recruiting
        • Nikolai Bunenkov
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikolai S Bunenkov
        • Sub-Investigator:
          • Aleksey V Sokolov, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: On-pump CABG.
Other: On-pump CABG
On-pump CABG
OTHER: Off-pump CABG.
Other: Off-pump CABG
Off-pump CABG
OTHER: Pump-assisted CABG.
Other: Pump-assisted CABG
Pump-assisted CABG
OTHER: Heart Valve Procedure without CABG.
Other: Valve Repair Procedure without CABG.
Valve Repair Procedure without CABG (open heart procedure).
OTHER: Heart Valve Procedure with CABG.
Other: Valve Repair Procedure with CABG.
Valve Repair Procedure with CABG (open heart procedure).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg State Pavlov Medical University

Investigators

  • Study Director: Alexander Nemkov, PhD, First Saint-Petersburg Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2018

Primary Completion (ANTICIPATED)

July 20, 2025

Study Completion (ANTICIPATED)

December 20, 2025

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (ACTUAL)

December 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 14, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • №22/18-H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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