search
Back to results

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

Primary Purpose

Cardiac Procedure Complication, Ischemic Heart Disease, Valve Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
On-pump CABG
Off-pump CABG
Pump-assisted CABG
Valve Repair Procedure without CABG.
Valve Repair Procedure with CABG.
Sponsored by
St. Petersburg State Pavlov Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiac Procedure Complication focused on measuring Ischemic Heart Disease, Valve Disease, Septal Defect, Myeloperoxidase, Molecular biology, Gene analysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nikolai BunenkovRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

On-pump CABG.

Off-pump CABG.

Pump-assisted CABG.

Heart Valve Procedure without CABG.

Heart Valve Procedure with CABG.

Arm Description

On-pump CABG.

Off-pump CABG.

Pump-assisted CABG.

Heart Valve Procedure without CABG.

Heart Valve Procedure with CABG.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 20, 2018
Last Updated
November 14, 2021
Sponsor
St. Petersburg State Pavlov Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT03786965
Brief Title
Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.
Acronym
MPO-CSP
Official Title
Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
July 20, 2025 (Anticipated)
Study Completion Date
December 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Petersburg State Pavlov Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Procedure Complication, Ischemic Heart Disease, Valve Heart Disease, Defect Septal
Keywords
Ischemic Heart Disease, Valve Disease, Septal Defect, Myeloperoxidase, Molecular biology, Gene analysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
On-pump CABG.
Arm Type
Other
Arm Description
On-pump CABG.
Arm Title
Off-pump CABG.
Arm Type
Other
Arm Description
Off-pump CABG.
Arm Title
Pump-assisted CABG.
Arm Type
Other
Arm Description
Pump-assisted CABG.
Arm Title
Heart Valve Procedure without CABG.
Arm Type
Other
Arm Description
Heart Valve Procedure without CABG.
Arm Title
Heart Valve Procedure with CABG.
Arm Type
Other
Arm Description
Heart Valve Procedure with CABG.
Intervention Type
Other
Intervention Name(s)
On-pump CABG
Intervention Description
On-pump CABG
Intervention Type
Other
Intervention Name(s)
Off-pump CABG
Intervention Description
Off-pump CABG
Intervention Type
Other
Intervention Name(s)
Pump-assisted CABG
Intervention Description
Pump-assisted CABG
Intervention Type
Other
Intervention Name(s)
Valve Repair Procedure without CABG.
Intervention Description
Valve Repair Procedure without CABG (open heart procedure).
Intervention Type
Other
Intervention Name(s)
Valve Repair Procedure with CABG.
Intervention Description
Valve Repair Procedure with CABG (open heart procedure).
Primary Outcome Measure Information:
Title
Death within 30 days after procedure.
Description
Death within 30 days after surgical procedure.
Time Frame
within 30 days after procedure.
Title
Acute myocardial infarction.
Description
Acute myocardial infarction (ST-changes with troponin I > 10 ng/ml).
Time Frame
within 30 days after procedure.
Title
Stroke.
Description
Stroke (MRI changes or corresponding neurologist record).
Time Frame
within 30 days after procedure.
Title
Arrhythmia
Description
Any type of arrhythmia including AV-block.
Time Frame
within 30 days after procedure.
Title
Renal dysfunction.
Description
Renal dysfunction if serum creatinine greater than 25% of upper reference range.
Time Frame
within 30 days after procedure.
Title
Infection or febrile.
Description
Infection or febrile (t> 37 or CRP elevation or long regeneration of surgical wound).
Time Frame
within 30 days after procedure.
Title
Respiratory dysfunction.
Description
Respiratory dysfunction (pulmonary ventilation longer than 2 days).
Time Frame
within 30 days after procedure.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Nemkov, PhD
Phone
+7-921-795-00-47
Email
nemk_as@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Komok, PhD
Phone
+7-904-632-19-00
Email
vladimir_komok@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Nemkov, PhD
Organizational Affiliation
First Saint-Petersburg Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nikolai Bunenkov
City
Saint-Petersburg
State/Province
Non-US/Non-Canadian
ZIP/Postal Code
194358
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolay Bunenkov
Phone
+7-950-028-17-40
Email
bunenkov2006@gmail.com
First Name & Middle Initial & Last Name & Degree
Vladimir V Komok, Ph.D
Phone
+7 904 632 19 00
Email
vladimir_komok@mail.ru
First Name & Middle Initial & Last Name & Degree
Nikolai S Bunenkov
First Name & Middle Initial & Last Name & Degree
Aleksey V Sokolov, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data are confidential.

Learn more about this trial

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

We'll reach out to this number within 24 hrs