Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.
MPO-CSP
1 other identifier
interventional
2,000
1 country
1
Brief Summary
The main objection is to investigate molecular biology of myocardial damage during cardiac surgery procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2018
CompletedStudy Start
First participant enrolled
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2025
CompletedNovember 16, 2021
November 1, 2021
6.6 years
December 20, 2018
November 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Death within 30 days after procedure.
Death within 30 days after surgical procedure.
within 30 days after procedure.
Acute myocardial infarction.
Acute myocardial infarction (ST-changes with troponin I \> 10 ng/ml).
within 30 days after procedure.
Stroke.
Stroke (MRI changes or corresponding neurologist record).
within 30 days after procedure.
Arrhythmia
Any type of arrhythmia including AV-block.
within 30 days after procedure.
Renal dysfunction.
Renal dysfunction if serum creatinine greater than 25% of upper reference range.
within 30 days after procedure.
Infection or febrile.
Infection or febrile (t\> 37 or CRP elevation or long regeneration of surgical wound).
within 30 days after procedure.
Respiratory dysfunction.
Respiratory dysfunction (pulmonary ventilation longer than 2 days).
within 30 days after procedure.
Study Arms (5)
On-pump CABG.
OTHEROn-pump CABG.
Off-pump CABG.
OTHEROff-pump CABG.
Pump-assisted CABG.
OTHERPump-assisted CABG.
Heart Valve Procedure without CABG.
OTHERHeart Valve Procedure without CABG.
Heart Valve Procedure with CABG.
OTHERHeart Valve Procedure with CABG.
Interventions
Valve Repair Procedure without CABG (open heart procedure).
Valve Repair Procedure with CABG (open heart procedure).
Eligibility Criteria
You may qualify if:
- ischemic heart disease with indications for operation
- valve disease with indications for operation
- ischemic heart disease combined with valve disease with indications for operation
You may not qualify if:
- patient refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nikolai Bunenkov
Saint Petersburg, Non-US/Non-Canadian, 194358, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexander Nemkov, PhD
First Saint-Petersburg Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 20, 2018
First Posted
December 26, 2018
Study Start
December 20, 2018
Primary Completion
July 20, 2025
Study Completion
December 20, 2025
Last Updated
November 16, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share
Individual participant data are confidential.