Cardiac Procedure ComplicationMPO-CSPNCT03786965
Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.
A study testing On-pump CABG, Off-pump CABG and Pump-assisted CABG in people with Cardiac Procedure Complication and Ischemic Heart Disease, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
The main objection is to investigate molecular biology of myocardial damage during cardiac surgery procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Procedure Complication, Ischemic Heart Disease, Valve Heart Disease
- What is being tested?
- On-pump CABG, Off-pump CABG and Pump-assisted CABG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteRussia
- Study dates
- 20 Dec 2018to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ischemic heart disease with indications for operation
- valve disease with indications for operation
- ischemic heart disease combined with valve disease with indications for operation
Who cannot join
- patient refusal
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Nikolai Bunenkov
Saint Petersburg, Non-US/Non-Canadian, 194358
Nikolay Bunenkov, +7-950-028-17-40, bunenkov2006@gmail.com
Vladimir V Komok, Ph.D, +7 904 632 19 00, vladimir_komok@mail.ru
About this study
The main objection is to investigate molecular biology of myocardial damage during cardiac surgery procedures.
Read the 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.
- Conditions
- Cardiac Procedure Complication, Ischemic Heart Disease, Valve Heart Disease, Defect Septal
- Being tested
- On-pump CABG, Off-pump CABG, Pump-assisted CABG, Valve Repair Procedure without CABG., Valve Repair Procedure with CABG.
- Keywords
- Ischemic Heart Disease, Valve Disease, Septal Defect, Myeloperoxidase, Molecular biology, Gene analysis
- Medical subject headings
- Myocardial Ischemia, Heart Valve Diseases, Heart Septal Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-pump CABGOther
On-pump CABG
Off-pump CABGOther
Off-pump CABG
Pump-assisted CABGOther
Pump-assisted CABG
Valve Repair Procedure without CABG.Other
Valve Repair Procedure without CABG (open heart procedure).
Valve Repair Procedure with CABG.Other
Valve Repair Procedure with CABG (open heart procedure).
| Study group | Role | What they receive |
|---|---|---|
| On-pump CABG. | Other | On-pump CABG. Receives: Other: On-pump CABG |
| Off-pump CABG. | Other | Off-pump CABG. Receives: Other: Off-pump CABG |
| Pump-assisted CABG. | Other | Pump-assisted CABG. Receives: Other: Pump-assisted CABG |
| Heart Valve Procedure without CABG. | Other | Heart Valve Procedure without CABG. Receives: Other: Valve Repair Procedure without CABG. |
| Heart Valve Procedure with CABG. | Other | Heart Valve Procedure with CABG. Receives: Other: Valve Repair Procedure with CABG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death within 30 days after procedure.
Death within 30 days after surgical procedure.
Measured: within 30 days after procedure.
Acute myocardial infarction.
Acute myocardial infarction (ST-changes with troponin I > 10 ng/ml).
Measured: within 30 days after procedure.
Stroke.
Stroke (MRI changes or corresponding neurologist record).
Measured: within 30 days after procedure.
Arrhythmia
Any type of arrhythmia including AV-block.
Measured: within 30 days after procedure.
Renal dysfunction.
Renal dysfunction if serum creatinine greater than 25% of upper reference range.
Measured: within 30 days after procedure.
Infection or febrile.
Infection or febrile (t> 37 or CRP elevation or long regeneration of surgical wound).
Measured: within 30 days after procedure.
Respiratory dysfunction.
Respiratory dysfunction (pulmonary ventilation longer than 2 days).
Measured: within 30 days after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start20 Dec 2018
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Procedure ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandr Nemkov, St. Petersburg State Pavlov Medical University
- Investigators
- Alexander Nemkov, PhD, Study director, First Saint-Petersburg Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786965
- Sponsor's protocol ID
- №22/18-H
- Acronym
- MPO-CSP
- Status last verified
- Nov 2021
- First submitted
- 20 Dec 2018
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are confidential.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.
- ClinicalTrials.gov ID
- NCT03786965
- Acronym / sponsor ID
- MPO-CSP / №22/18-H
- Conditions
- Cardiac Procedure Complication, Ischemic Heart Disease, Valve Heart Disease, Defect Septal
- Keywords
- Ischemic Heart Disease, Valve Disease, Septal Defect, Myeloperoxidase, Molecular biology, Gene analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| On-pump CABG. | Other | Other: On-pump CABGOn-pump CABG. |
| Off-pump CABG. | Other | Other: Off-pump CABGOff-pump CABG. |
| Pump-assisted CABG. | Other | Other: Pump-assisted CABGPump-assisted CABG. |
| Heart Valve Procedure without CABG. | Other | Other: Valve Repair Procedure without CABG.Heart Valve Procedure without CABG. |
| Heart Valve Procedure with CABG. | Other | Other: Valve Repair Procedure with CABG.Heart Valve Procedure with CABG. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ischemic heart disease with indications for operation
- valve disease with indications for operation
- ischemic heart disease combined with valve disease with indications for operation
Key exclusion criteria (1 listed)
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-pump CABGOn-pump CABG | Other | On-pump CABG. |
| Off-pump CABGOff-pump CABG | Other | Off-pump CABG. |
| Pump-assisted CABGPump-assisted CABG | Other | Pump-assisted CABG. |
| Valve Repair Procedure without CABG.Valve Repair Procedure without CABG (open heart procedure). | Other | Heart Valve Procedure without CABG. |
| Valve Repair Procedure with CABG.Valve Repair Procedure with CABG (open heart procedure). | Other | Heart Valve Procedure with CABG. |
Primary outcome
Death within 30 days after procedure.
Time frame: within 30 days after procedure.
Death within 30 days after surgical procedure.
Acute myocardial infarction.
Time frame: within 30 days after procedure.
Acute myocardial infarction (ST-changes with troponin I > 10 ng/ml).
Stroke.
Time frame: within 30 days after procedure.
Stroke (MRI changes or corresponding neurologist record).
Arrhythmia
Time frame: within 30 days after procedure.
Any type of arrhythmia including AV-block.
Renal dysfunction.
Time frame: within 30 days after procedure.
Renal dysfunction if serum creatinine greater than 25% of upper reference range.
Infection or febrile.
Time frame: within 30 days after procedure.
Infection or febrile (t> 37 or CRP elevation or long regeneration of surgical wound).
Respiratory dysfunction.
Time frame: within 30 days after procedure.
Respiratory dysfunction (pulmonary ventilation longer than 2 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No. Individual participant data are confidential.
Related trials for Cardiac Procedure Complication
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Nemkov, PhD study director
First Saint-Petersburg Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-pump CABG, Off-pump CABG and Pump-assisted CABG in people with Cardiac Procedure Complication and Ischemic Heart Disease, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Nemkov, PhD (+7-921-795-00-47, nemk_as@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death within 30 days after procedure. (time frame: within 30 days after procedure.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.