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

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ClinicalTrials.gov Identifier: NCT03786965
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Aleksandr Nemkov, St. Petersburg State Pavlov Medical University

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

Condition or disease Intervention/treatment Phase
Cardiac Procedure Complication Ischemic Heart Disease Valve Heart Disease Defect Septal Other: On-pump CABG Other: Off-pump CABG Other: Pump-assisted CABG Other: Valve Repair Procedure without CABG. Other: Valve Repair Procedure with CABG. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : July 20, 2025
Estimated Study Completion Date : December 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
On-pump CABG.
On-pump CABG.
Other: On-pump CABG
On-pump CABG

Off-pump CABG.
Off-pump CABG.
Other: Off-pump CABG
Off-pump CABG

Pump-assisted CABG.
Pump-assisted CABG.
Other: Pump-assisted CABG
Pump-assisted CABG

Heart Valve Procedure without CABG.
Heart Valve Procedure without CABG.
Other: Valve Repair Procedure without CABG.
Valve Repair Procedure without CABG (open heart procedure).

Heart Valve Procedure with CABG.
Heart Valve Procedure with CABG.
Other: Valve Repair Procedure with CABG.
Valve Repair Procedure with CABG (open heart procedure).




Primary Outcome Measures :
  1. Death within 30 days after procedure. [ Time Frame: within 30 days after procedure. ]
    Death within 30 days after surgical procedure.

  2. Acute myocardial infarction. [ Time Frame: within 30 days after procedure. ]
    Acute myocardial infarction (ST-changes with troponin I > 10 ng/ml).

  3. Stroke. [ Time Frame: within 30 days after procedure. ]
    Stroke (MRI changes or corresponding neurologist record).

  4. Arrhythmia [ Time Frame: within 30 days after procedure. ]
    Any type of arrhythmia including AV-block.

  5. Renal dysfunction. [ Time Frame: within 30 days after procedure. ]
    Renal dysfunction if serum creatinine greater than 25% of upper reference range.

  6. Infection or febrile. [ Time Frame: within 30 days after procedure. ]
    Infection or febrile (t> 37 or CRP elevation or long regeneration of surgical wound).

  7. Respiratory dysfunction. [ Time Frame: within 30 days after procedure. ]
    Respiratory dysfunction (pulmonary ventilation longer than 2 days).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786965


Contacts
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Contact: Alexander Nemkov, PhD +7-921-795-00-47 nemk_as@mail.ru
Contact: Vladimir Komok, PhD +7-904-632-19-00 vladimir_komok@mail.ru

Locations
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Russian Federation
Nikolai Bunenkov Recruiting
Saint-Petersburg, Non-US/Non-Canadian, Russian Federation, 194358
Contact: Nikolay Bunenkov    +7-950-028-17-40    bunenkov2006@gmail.com   
Contact: Vladimir V Komok, Ph.D    +7 904 632 19 00    vladimir_komok@mail.ru   
Principal Investigator: Nikolai S Bunenkov         
Sub-Investigator: Aleksey V Sokolov, PhD         
Sponsors and Collaborators
St. Petersburg State Pavlov Medical University
Investigators
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Study Director: Alexander Nemkov, PhD First Saint-Petersburg Medical University

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Responsible Party: Aleksandr Nemkov, PhD, St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT03786965     History of Changes
Other Study ID Numbers: №22/18-H
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data are confidential.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aleksandr Nemkov, St. Petersburg State Pavlov Medical University:
Ischemic Heart Disease
Valve Disease
Septal Defect
Myeloperoxidase
Molecular biology
Gene analysis

Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Heart Valve Diseases
Heart Septal Defects
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities